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Rimsys Announces Rimsys AI to Eliminate Repetitive Tasks and Enhance Decision-Making for MedTech Regulatory Teams
Rimsys, the leading Regulatory Information Management (RIM) platform for the MedTech industry, today announced the launch of Rimsys AI, a suite of embedded artificial intelligence (AI) agents.
The beginner's guide to the FDA De Novo classification process
This article is an excerpt from The beginner's guide to the FDA De Novo classification process ebook.
Contents
- Introduction
- Chapter 1: What is an FDA De Novo request?
- Chapter 2: Contents of a De Novo request
- Chapter 3: Submitting a De Novo request
- Appendix A: Acceptance review checklist
Congratulations, you have successfully developed a new medical device! Now you need to take it to market. Normally in the United States this would mean completing a 510(k) submission. However, the 510(k) relies on “substantial equivalence”—a comparison to a similar device already on the market (also called a predicate device) to assess the risk profile of the new device. What if your device is totally new, and there isn’t a similar device to compare it to? Enter the FDA De Novo process. The De Novo process provides a pathway to market for novel devices with a low to medium risk profile.
What does De Novo mean?
According to the Merriman-Webster dictionary, de novo is a Latin word meaning “as if for the first time; or anew.” Perfectly fitting that the FDA uses this term “De Novo” to describe market approval requests for new medical devices or technology where there is no comparable predicate device on the market.
The Food and Drug Administration Modernization Act of 1996 provided the FDA with the authority to create the De Novo Classification Process. It's a process that uses a risk-based strategy for a new, novel kind of medical device, in vitro diagnostic, or medical software solution whose type has previously not been identified and/or classified. It’s a process by which a novel medical device can be classified as a Class I or Class II device, instead of being automatically classified as Class III, which may not be appropriate. Before the implementation of the De Novo process in 1997, all the “not substantially equivalent” (NSE) products were required to be initially classified as a Class III device. But for a lot of devices, this risk class didn’t really make sense. The De Novo process provides a pathway for more accurate classifications of novel, lower-risk devices.
October, 2021, the FDA released a final guidance document "De Novo Classification Process (Evaluation of Automatic Class III Designation)" to provide guidance to the requester (also known as the manufacturer) and the FDA on the process for the submission and review of a De Novo Classification Request under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This process provides a pathway to an initial Class I or Class II risk classification for medical devices for which general controls or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. This guidance document replaced the "New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff" document, dated February 19, 1998.
Consistent with the final rule, the FDA updated the guidance documents below to provide recommendations for submitting De Novo requests, as well as criteria and procedures for accepting, withdrawing, reviewing, and making decisions on De Novo requests, effective January 3, 2022.
- User Fees and Refunds for De Novo Classification Requests
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review clock and Goals
- Acceptance Review for De Novo Classification Requests
The 510(k) and the De Novo processes are similar in that they are both pathways to market for medical devices with low to moderate risk, which is Class I and Class II. The biggest difference between the two is that the 510(k) heavily relies on the concept of "substantial equivalence" to an existing medical device. You must prove this to get the clearance of your 510(k) submission. In the De Novo process, there isn’t a product currently on the market that is “substantially equivalent” to yours, so it’s like starting with a clean slate. For more on the 510(k) process, see our Beginner’s Guide to the 510(k) ebook.
A result of the De Novo process to be aware of is that a successful submission will lead to a new predicate device type that someone else can reference to bring their product to market through the 510(k) process. You’ve done all the work, so now it’s available for anyone to use to provide "substantial equivalence".
De Novo history/timeline
Preparing a De Novo request
1. Do your research! Be sure to complete all the necessary research prior to your submission. You want to be sure that your device is not substantially equivalent to an existing device. Resources to review include:
- The Center for Devices and Radiological Health (CDRH)
- U.S. FDA Device Classification Database
- Device Classification Under Section 513(f)(2)(De Novo)
2. A De Novo request can be submitted with or without a preceding 510(k). There are two options for when you can submit a De Novo request:
Option A: After receiving a not substantially equivalent (NSE) determination (that is, no predicate, new intended use, or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission.
Option B: If you’ve determined, after extensive research, that there is no legally marketed device on which to base a determination of substantial equivalence.
3. Be sure all fees are paid to the FDA in advance of submitting a De Novo request. The FDA’s fiscal year begins in October and runs through the following September. Fees have increased each year since they were introduced, but the FDA’s percentage of reviews completed within the 150-day window has increased as well.
A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of the FDA user fees, including De Novo. The CDRH is responsible for the Small Business Program that determines whether a business is qualified.
Medical Device User Fee Amendments (MDUFA) guidance documents can provide more detailed information about all FDA user fees.
4. The initial request process serves only to determine if the De Novo request is administratively acceptable based upon the Acceptance Checklist. The initial acceptance is followed by substantive review which will determine the final risk classification of your device.
5. A Pre-Submission (Pre-Sub) is a formal written request for feedback from the FDA that is provided in formal written form, and then followed by a meeting. Although a Pre-Sub is not required prior to a De Novo request, it can be extremely helpful to receive early feedback, especially for devices that have not previously been reviewed under a 510(k). If you think you would like to submit a pre-sub first, there are suggested guidelines for submission you should consider:
- Describe your rationale for a Class I or Class II classification for your device.
- Provide the search results of FDA public databases and other resources used to determine that no legally marketed device and no classification for the same device type exists.
- Provide a list of regulations and/or product codes that may be relevant.
- Provide a rationale for why the subject device does not fit within and/or is different from any identified classification regulations, based on available information.
- Identify each health risk associated with the device and the reason for each risk.
- Briefly describe any ongoing and/or planned protocols/studies that need to be completed in order to collect the necessary data to establish the device’s risk profile.
- Provide information regarding the safety and effectiveness of the device. Cite the types of valid scientific evidence you anticipate providing in your De Novo request, including types of data/studies relating to the device’s safety and effectiveness.
- Briefly describe any ongoing and/or planned protocols/studies that need to be completed to collect the necessary safety and effectiveness data.
- Provide protocols for non-clinical and clinical studies (if applicable), including how they will address the risks you anticipate and targeted performance levels that will demonstrate that general controls or general and special controls are sufficient to provide reasonable assurance of safety and effectiveness.
- Share any proposed mitigation measure(s)/control(s) for each risk, based on the best available information at the time of the submission. Highlight which mitigations are general controls and which are special controls and provide details on each.
- Include any other risks that may be applicable, in addition to those identified in the Pre-Sub, given the indications for use for the device.
- If applicable, provide any controls that should be considered to provide a reasonable assurance of safety and effectiveness for the device.
- Provide any non-clinical study protocols that are sufficient to allow the collection of data from which conclusions about device safety and/or effectiveness can be drawn. These protocols should address whether the identified level of concern is the appropriate level of concern for the device software, and if any additional biocompatibility and/or sterility testing is required.
- If clinical data is needed, provide information to show that the proposed study design and selected control groups are appropriate?
6. The FDA will attempt to review the De Novo request submission within 15 calendar days of receipt of the request to make a determination that the submission is declined or accepted for review. If they are unable to complete the review within the 15 days, your submission will automatically move to “accepted for review” status. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation
7. There are times when the FDA will refund your application fee. They have created a guidance document “User Fees and Refunds for De Novo Classification Requests” for the purpose of identifying:
- the types of De Novo requests subject to user fees
- exceptions to user fees
- the actions that may result in refunds of user fees that have been paid
When is a De Novo request subject to a user fee?
When will the FDA refund a De Novo user fee?
What fee must be paid for a new device submission following a De Novo “decline” determination?
To continue reading this eBook including a detailed walk-through of all the Traditional 510(k) components, submission requirements and timelines, and an overview of the other 510(k) forms including the Abbreviated 510(k) and the Special 510(k), please register to download the full version.
The ultimate guide to the medical device single audit program (MDSAP)
This article is an excerpt from The ultimate guide to the medical device single audit program (MDSAP) ebook.
Table of contents
- What is MDSAP?
- History of MDSAP
- Who is responsible for the MDSAP?
- How does an MDSAP audit work?
- Audit sequence
- You got a nonconformity – now what?
- What does an MDSAP audit cost?
- Why choose the MDSAP certification process?
- Potential disadvantages of the MDSAP
- Ready to participate? – Here’s how to get started
- Completing a successful MDSAP audit
The Medical Device Single Audit Program (MDSAP) was designed and developed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. The MDSAP provides efficient and thorough coverage of the standard requirements for medical device manufacturer quality management systems, and requirements for regulatory purposes (ISO 13485:2016). In addition, there are specific requirements of each medical device regulatory authority participating in the MDSAP that must be met:
- Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
- Brazilian Good Manufacturing Practices (RDC ANVISA 16)
- Medical Device Regulations of Health Canada (ISO 13485:2003)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No 169)
- Quality System Regulation (21 CFR Part 820), and specific requirements of medical device regulatory authorities participating in the MDSAP program.
This means that a report from a single MDSAP audit of a medical device manufacturer would be accepted as a substitute for routine inspections by all the member Regulatory Authorities (RAs) across the world. There are currently five participating Regulatory Authorities (RA) representing the following countries: Australia, Brazil, Canada, Japan and the USA.
In April, 2021, the RAs released an “Audit Approach” document (MDSAP AU P0002.006) that combines the formerly separate MDSAP Audit Model and Process Companion documents into a single guidance document. It includes guidance for assessing the conformity of each process and includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes.
In March 2012 the US FDA announced that they had approved a final pilot guidance document “Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.” This allowed the owner or operator of a medical device manufacturing facility to be removed from FDA’s routine inspection work plan for 1 year upon completing a ISO 13485:2003 audit. This guidance document went into effect in June 2012, and was intended as an interim measure while a single audit program was being developed.
This pilot program was not very successful and few companies signed up because they did not see any advantage in participating. The manufacturer had to pay for a third party to inspect their facilities, generate a report, and share the inspection results back to the FDA. Many companies were reluctant to contract “someone else” to perform their inspection when they could easily wait for the FDA to conduct an inspection for free.
During its inaugural meeting in Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) appointed a working group to develop a set of documents for a harmonized third-party auditor system. Hence, the “Medical Device Single Audit Program” (MDSAP) was formed. The concept was similar to the FDA’s original idea of creating a third-party auditor to help reduce their workload of performing regulatory audits of medical device manufacturers’ quality management systems. This new approach would consist of a single audit that would review regulatory QMS compliance, conducted by a third-party, who would later be called an Auditing Organization (AO).
From January 2014 to December 2016, five countries participated in a Medical Device Single Audit Program Pilot. In June 2017, a report was generated summarizing the outcomes of prospective “proof- of-concept” criteria established to confirm the success of the program. The outcomes are documented in the final MDSAP Pilot Report and recommended that the program become fully active and open to any manufacturer who requested this type of audit.
The governing body of the MDSAP is the Regulatory Authority Council (RAC), which is composed of two senior managers (and a few other staff members) from each participating RA. They are responsible for executive planning, strategic priorities, setting policy, and making decisions on behalf of the MDSAP International Consortium. The RAC also reviews and approves documents, procedures, work instructions, and more. The mission of the MDSAP International Consortium is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers on a global scale.
Other international partners that are involved in the MDSAP include:
MDSAP Observers:
- European Union (EU)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
- Singapore’s Health Sciences Authority (HSA)
The observers and affiliate members are not the same as the participating member RA’s. The observers simply observe and/or contribute to RAC activities. Affiliate members, on the other hand, are interested in engaging in the MDSAP program and are subject to certain rules. They are only given access to a certain level of information about the manufacturers, audit dates, and information in audit reports.
They are also invited to attend sessions that are open to members, observers, and affiliates only.
Audits can also be conducted by MDSAP participating RAs at any time and for various reasons including:
- "For Cause" due to information obtained by the regulatory authority
- as a follow up to findings from a previous audit
- to confirm the effective implementation of the MDSAP requirements
The purpose of audits conducted by the RAs is to ensure appropriate oversight of the AOs MDSAP auditing activities. The AOs are appointed by the RAs and a list of the currently approved AO’s is published on the FDA website. Most AOs offer a broad range of management system certification services, beyond just medical devices. Manufacturers should verify that prospective AOs are clearly trained and perform MDSAP audits of medical devices.
AOs have the final word as to whether a manufacturer has met the requirements for the MDSAP during the execution of the audit and generation of the associated reports summarizing the results. MSDAP RAC participating RAs have the final decision regarding all development, implementation, maintenance, and expansion activities associated with the program.
Although an unannounced visit by an AO is rare, it can happen in circumstances where high-grade nonconformities have been detected.
To continue reading this eBook including a detailed look at the MDSAP audit process and grading, pros and cons of the approach, and how to get started please register to download the full version.
Content of FDA premarket submissions for device software functions
The Food and Drug Administration (FDA) recently released a final guidance document, “Content of Premarket Submissions for Device Software Functions.” This document is intended to provide information about the recommended documentation that medical device manufacturers should include in premarket submissions for the FDA's evaluation of safety and effectiveness of device software functions. This document replaces the FDA's “Content of Premarket Submissions for Software Contained in Medical Devices” document issued in May, 2005. Note: This new guidance does not apply to automated manufacturing and quality system software or software that is not a device.
In general, the FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance’s describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Highlight of changes to FDA guidance on premarket submissions for device software
Since the last time this document was revised (2005), there have been many updates to this new guidance document that are certainly worth noting. Along with the multiple changes and additions, this guide will help with more clarity in the process of determining software documentation for premarket submission and review of software medical devices, or devices that have a software function.
Some of the highlights that are important to mention include:
- Changes in terminology to more current trends. For example, the Hazard Analysis is now referred to as the Risk Management File.
- The table of contents has been extended and divided into several sections, broken down even further to include documentation type and Documentation Level.
- Level of Concern is now referred to as Documentation Levels. Although still guided by the level of product “risk," instead of major, moderate, and minor levels, they are now identified as Basic or Enhanced Levels. Basic is any premarket submission that includes device software function(s) where Enhanced Documentation does not apply. Enhanced includes device software function(s) where a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.
- The Recommended Documentation section (formerly the Software-related Documentation) section has expanded to include more detail and subsections about software requirements, software architecture, software design, software development, software testing, software version history, and unresolved software anomalies.
- The Software Description has been revised to add reference to guidance about Multiple Function Device products that extends into software operation, software specifics, and software inputs/outputs.
- The Hazard Analysis is now the Risk Management file and continues to recommend ISO 14971 for guidance. It’s also been extensively revised to include the risk management plan, the risk assessment and risk management report.
- Newly added Appendix A provides many Documentation Level examples intended to demonstrate the implementation of the Documentation Level risk-based approach. Over 20+ product examples are included in this list.
- Newly added Appendix B provides examples of diagrams for the purpose of demonstrating how the System and Software Architecture Diagram could be implemented into diagrams, and to help show a clear understanding of the system and software.
In addition to this new guidance, the FDA recommends reviewing the following guidance documents (which is not an exhaustive list) for additional support in determining premarket software documentation for submission.
- Multiple Function Device Products: Policy and Considerations
- Off-The-Shelf Software Use in Medical Devices
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices
- General Principles of Software Validation
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software
- Applying Human Factors and Usability Engineering to Medical Devices
Selecting a RIM system for your medical device company
Software for medical device regulatory teams
Many regulatory affairs (RA) teams within medical device organizations are still managing their activities through spreadsheets, in-house custom-built software, or systems designed for other purposes. We believe that regulatory teams deserve purpose-built software that allows them to ensure compliance across products and markets, and provides them with the opportunity to contribute directly to revenue-driving activities.
Regulatory Information Management (RIM) solutions provide the centralized regulatory functionality needed by today’s RA teams. RIM solutions such as Rimsys are product-centric, allowing regulatory professionals to track all product-specific information and then create market submissions, link standards and essential principles, manage registrations by product by market, and control all regulatory approvals and projects. However, not all RIM solutions are created equal. If you have complex products, devices that include software, or other requirements that not all medical device companies will have, be sure to carefully evaluate potential systems for their ability to address those needs.
Justifying the need for RIM
Any software selection project begins with analyzing the need for the new software, creating a justification for the project, and obtaining the approval and budget to move forward. RIM solutions will allow your RA team to find information more quickly and operate more efficiently, which means that justification for a new RIM system typically comes from four areas:
- Cost savings – RA teams can operate more efficiently, reducing the need for outside consultants or contractors and enabling new RA team members to onboard more quickly. Better information also allows RA teams to better forecast projects in order to optimize the internal team size.
- Reduced regulatory risk – A centralized RIM system reduces multiple risks, including missing an expiration date or supplying incorrect information to a regulatory body. Even a small misstep can cause an audit finding, removal of a product from a market, or a delay in entering a new market.
- Improved competitive advantage – RIM systems significantly reduce the time that RA teams spend finding data and reacting to last-minute “emergency” requests. This advantage allows the team to drive competitive advantages and greater revenue growth through participation in market planning, product roll-out decisions, and other strategic planning. One Rimsys customer was able to improve the time for a product release by 88%. By increasing speed to market, medtech companies can recognize revenue sooner and capture more market share more quickly.
- Data harmonization – Medtech companies dealing with duplicated data and systems due to mergers or acquisitions can point to a centralized RIM system as a way to harmonize important regulatory data to ensure compliance and optimize go-to-market activities.
You will likely need to develop a comprehensive business case to support any RIM investment. This will include detailing the limitations of current approaches (including spreadsheets and costs to maintain in-house systems), quantifying the expected benefits, and explaining the evaluation process to arrive at your preferred vendor. Building this as you work through the early stages of RIM selection will prevent delays as you move into the purchase process.
Should I use external consultants to help with RIM selection?
RIM selection projects are sometimes managed by in-house teams and sometimes managed by 3rd-party consultants. How do you decide which is right for your selection project?
Does your team have experience with large system selection projects?
If your organization has a large IT team and/or digital transformation team, they likely have the responsibility of overseeing the selection of any new software systems. Be sure to understand their capabilities – have members of the team managed large system selection projects before, such as ERP or PLM selections? The regulatory team and others within the organization can provide subject matter expertise, but you will be relying on the technical team to oversee the project, define requirements, help set a budget, and more.
If the right level of expertise does not exist within your organization, an outside consultant with medical device regulatory experience and with business system selection projects should be considered. This type of consultant can be extremely helpful during the system implementation and adoption phase of the project as well.
Does our team have the bandwidth to manage a RIM selection project?
Even if your organization has an internal team with the expertise to manage a RIM selection project, they may not have the time to do so within the desired project timeframe. In this case, an external consultant can augment your existing team to get the project completed as required.
Do we need a new perspective?
Selecting a RIM solution is as much about digital transformation and process optimization as it is about ensuring you find a system with the right features. Do you have a vision of where you want the RA team to be? Have you looked at the characteristics of top-performing RA teams? If you think you might need a new perspective and an outside voice, an outside consultant may be the right choice for your project.
RIM selection project steps
Once you have determined the need for a RIM system, a selection project should include the following major steps:
Build the selection team
Put together a core selection team that consists of:
- A project leader that is typically at a manager level or above within the organization and comes from the regulatory or IT teams.
- An executive sponsor who may not participate in all aspects of the project, but who will ensure that resources are made available to the team as needed and that the project is kept on track and is aligned with overall company goals.
- IT team member(s) who will provide feedback on technical system requirements, including security and data privacy, and will support customization and integration discussions.
- Subject matter experts representing each department and team who will be using or interacting with the software.
You will add team members once you begin to implement the system, but selection teams typically consist of fewer than 10 members.
Determine requirements and selection criteria
One of the primary responsibilities of the selection team is to define the requirements for the new system, and the criteria on which systems will be judged. Requirements usually fall into multiple categories, including:
- Business requirements – These are broad requirements based on business needs. They will typically answer the question “Why do we need a RIM system?” For example, reducing the administrative burden on the regulatory team with functionality that allows the team to track registration expiration dates, create submission dossiers, and quickly report on registration status by product and market. Include project timeline and budgetary constraints here as well.
- Functional or user requirements – Functional requirements are a more detailed list of specific functions that users will need to perform in the system. For example, the ability to link standards to essential principles, manage multiple approvals for submission documents, or track UDI product data. DO include requirements that are essential for users to complete their work within your defined quality procedures. DO NOT include requirements that are unnecessarily specific (ex: the product description must contain at least 50 characters) or are so common that all systems will meet the requirement (ex: there must be a product number and description in the product record).
- System and technical requirements – Your IT team may already have a list of the overall technical requirements that all software must meet within your organization. These will likely include data security requirements and features that support system validation. Include any specific requirements regarding system availability, upgrade management, and technical support guarantees. See SaaS 101 for medtech regulatory professionals for a list of questions that you should ask a SaaS solution provider. Also include here any procurement requirements that your organization has, such as insurance requirements.
- Vendor resources and vision – You want to work with a vendor that shares your vision, not only for this system implementation but also for future growth. Evaluate each vendor’s product roadmap and plans for innovation against your organization’s digital transformation plans for the next 2-5 years. Does the vendor share your vision? Do they have the resources to support your organization and that future vision?
Establish project goals and timelines
Establish project goals and an overall project timeline. Is there a hard deadline by which the system needs to be live? What are the goals and metrics with which the success of the project will be measured? Be sure to get written agreement from the project team and executive team on the goals, timeline, and how the information will be reported.
Research RIM vendors (build your initial list)
If you are working with an experienced regulatory consultant, they may be able to get you to your short list without this step. However, if you are unsure of which systems may meet your needs, begin by:
- Researching Regulatory Information Management systems online.
- Talking to other regulatory professionals for suggestions and referrals.
- Consulting with industry analysts. Gartner's annual RIM market guide, and Gens & Associates World Class RIM report both provide an overview of RIM vendors. (Note, however, that both include both pharma and medtech-focused solutions within their respective guides.)
Build vendor short list
Based on the information gathered in the previous step, you should be able to create a short list of two to six vendors. This may require short conversations with prospective vendors, but you should have your short list before you schedule product demos and/or send out a request for proposal (RFP).
Tip: If you communicate with vendors that don’t make your short list, let them know so that they don’t continue to contact you!
Evaluate vendor capabilities
This part of the project varies greatly from company to company, but your process should ensure that all of your stated requirements are being evaluated against each vendor’s capabilities. Not all team members need to evaluate all requirements – individuals should be assigned based on their understanding of the area being evaluated. The same people, however, should evaluate the same requirements across all vendors to ensure a fair comparison.
If your organization requires an RFI (request for information) or RFP (request for proposal), those need to be compiled and sent to the vendors as the starting point for vendor evaluations. These documents allow your team to gather the same information from all vendors. Put simply, these are documents that list your requirements and ask the vendors to indicate if they address them natively within their software, through third-party integrations, or not at all. Our RIM Buyer’s Guide provides a template that can be used as a starting point.
Whatever your evaluation process looks like, your team needs to see the software. For systems as large as RIM solutions, you may need multiple demonstrations with the vendor and your team. Work with the vendor to determine how the process will work, but typically you will have an overview demonstration and then separately schedule individual sessions, if they are needed, to cover specific features or answer additional questions. While everyone on the evaluation team should attend the initial demo, additional sessions should be scheduled only when needed and only with those team members required. The following can help ensure a smooth process:
- Communicate clearly to your team what they are responsible for during the demo. Who is taking notes? Are different team members responsible for evaluating features in different areas of the software?
- Set expectations with the vendor ahead of time and maintain control of the demo agenda. The software vendor will know what sequence works best for their product, and you should allow them to guide you. However, you will want to steer them away from spending too much time on features that are not important to your team.
- Ask the vendor to keep track of unanswered questions or features that you were unable to see. The vendor should be expected to follow-up on these items.
Rate and rank vendors
Using your requirements list, each vendor should be rated for each requirement. Require vendors to clearly indicate if a requirement is met “out of the box,” requires custom development work, or is not supported at all. Consider a scale of 0-5, with 0 being a feature the vendor does not support. Multiplying the rank by the importance of the feature (3 – Critical to have, 2- Important to have, 1- Nice to have), will give you a good picture of where each vendor ranks.
There should be some subjective items that are used in rating, also, such as how easy you believe the vendor will be to work with. Once the vendors are rated, the team should meet to discuss differences between team members' ratings and then to agree on where each vendor ranks. It is important that all requirements are considered and weighed appropriately while ranking vendors. For example, selecting the system with the best price may leave you with a vendor that doesn’t have the resources to support your implementation.
Negotiate and purchase
Hopefully, you will be able to successfully (and quickly) negotiate with your top-ranked vendor. However, it does sometimes happen that an agreement cannot be reached with the initial vendor for reasons that may include pricing adjustments or unexpected changes to the availability of their resources. In this case, you will need to move on to your second choice.
For more information on specific criteria for purchasing a RIM system, read our RIM Buyer’s Guide.
SaaS 101 for medtech regulatory professionals
What is Software as a Service (SaaS)?
SaaS, or Software as a Service, is a software delivery model in which applications are hosted by software vendors and provided to users via the internet. The use of SaaS software has skyrocketed in recent years, with an estimated 70% of business software being used falling into the SaaS category 2022.
Also known as a “cloud” delivery model, SaaS solution providers either host the application and related data using their own servers and computing resources or use a cloud service provider, such as Amazon Web Services (AWS) or Microsoft Azure, to host the application in the provider's data center. The hosted application is then accessible to any device with a network connection and is usually accessed via a web browser.
Many SaaS software systems use a multi-tenant architecture in which a single instance of the software serves many subscribers, or users. Customer data, while stored centrally, is logically separated to ensure security and prevent co-mingling of data. However, for software systems that require validation, such as regulatory information management systems, a single-tenant system can offer greater data security along with the flexibility for teams to fully validate software releases before adopting them.
What are the benefits of Saas?
- Reduced hardware costs – SaaS removes the need to install and maintain software locally, which reduces the cost of servers and related infrastructure.
- Subscription payments – SaaS software is typically billed on a monthly or annual subscription basis. Not only does this allow companies to spread out the cost of the system, but a subscription model also allows for shorter commitment periods vs. a large up-front capital expenditure (CapEx vs OpEx). The SaaS model also holds software providers more accountable than other models given that the user has the option to cancel or not renew a SaaS subscription, leading to higher levels of service and support.
- Scalable usage – SaaS service providers automatically scale the resources needed to support users and can provide additional services or features on demand.
- Seamless software maintenance – SaaS software can be automatically updated with new features and, when necessary, patched with bug fixes. While this simplifies software maintenance from the user’s end, users in the medtech industry should expect to be able to test and validate software updates before they are installed on their system.
- Accessibility – Accessed via the Internet, SaaS solutions are available from almost any device in any location.
- Reliability – Because SaaS solution providers have extensive resources, beyond what any individual company would normally have, SaaS software typically has very high reliability and availability in comparison to in-house systems.
- Security – SaaS solution providers deliver state-of-the-art security and privacy at a level that is difficult for individual companies to maintain.
As a regulatory professional, what questions should I ask a SaaS vendor?
How are software updates managed?
SaaS software providers generally install new features, bug fixes, and other updates automatically. However, medical device regulations, such as the FDA’s 21CFR Part 11 and EU’s MDR, require medtech companies to validate any software that they are using that is integral to their quality system or otherwise might affect the safety or efficacy of the devices which they manufacture.
Therefore, a SaaS company providing solutions to the medtech industry should offer the ability for subscribers to review and validate software updates before they are installed. This is often done by providing a transition period during which the software vendor allows access to the new version of the software and the existing version. In addition, many software providers, such as Rimsys, will turn off new features by default and allow the user to enable the new feature if and when they want to begin using it. Be sure to understand what, if any, updates will be installed without this review period. Some software vendors will push small bug fixes and minor features automatically.
Clients should be notified of any updates in a timely manner and, ideally, have access to a non-production version of the software for testing purposes. Be sure to understand how often updates will become available and how often those updates are expected to trigger a re-validation of the system. While every medtech organization will have their own specific policies on this matter, Rimsys communicates the expected impact on software validation of each new release, and the reasoning behind whether an update will or will not require a new validation.
Do you assist with software validation?
While software validation is ultimately the responsibility of the medtech company using the software, there is a lot that a software vendor can do to assist with this process. The software vendor should be able to provide documentation concerning the design, development, and testing of the systems that they are providing. In addition, some vendors will provide test cases that can be used by your own team to test and validate the software. These test cases significantly reduce the burden on the in-house validation team.
SaaS vendors should also be able to provide medtech companies with their Computer Software Assurance (CSA) plan. In most cases, the FDA and similar regulatory agencies are looking for compliance with a CSA plan in lieu of the more onerous Computer System Validation (CSV) process that was traditionally followed in the past.
How do you handle data security?
This should be an easy question for any SaaS provider to answer. Whether the data is being hosted by a cloud service provider, such as AWS, or by the vendor themselves, there should be a documented data security plan. As part of that plan, the software vendor should be able to demonstrate how data is protected through physical and logical separation within the system and the application of robust encryption to the data both at rest and in transit. Additionally, the vendor should have a well-documented information security management system (ISMS), which can be further evaluated by third parties for adherence to SOC 2 Type 2 and ISO 27001.
What is your uptime SLA?
SaaS providers should provide uptime guarantees in writing, typically within a Service Level Agreement (SLA). The majority of SaaS business software providers will offer uptime guarantees between 95% and 99%. For mission-critical solutions, such as RIM systems, expect guarantees at, or close to, 99%.
What happens to our data if we leave?
Because you are not storing your data locally, be sure to understand what will happen to your data if you choose to terminate your contract with a SaaS solution provider. You should be able to access your data after termination, download data prior to termination, or both. Ask if you will be charged for this.
Can I access and report on all of my data, all of the time?
It is important to know that you will be able to access all of your data at any point in time, especially during an audit or inspection. Can you create reports that reference any and all data fields in the system? Will older data be archived automatically at any point? Are there API’s available to allow other systems to access the data?
What are your fees based on?
SaaS companies can base their fees on a variety of factors, including data usage, number of users, and features used. Be sure to understand all of the factors that may affect your subscription fees now and in the future.
SaaS terms to know
- SLA: An SLA is a “Service Level Agreement,” which serves as the contract defining what the SaaS vendor is providing and what the customer expects to receive. Among other things, the SLA will define uptime guarantees, what counts as downtime, the procedures followed in the case of a data breach, and how termination of the contract is handled.
- Uptime: Uptime is the percentage of time during which the SaaS software is operational and available to subscribers. The specifics of how uptime is measured should be part of the SLA. Downtime is the converse of uptime.
- API: API, or Application Programming Interface, is a set of definitions and protocols provided by software applications to allow data sharing and integration between applications.
- Module: A part of the software platform that is dedicated to a specific function and outcome. SaaS pricing is often organized around the purchase of one or multiple modules.
- Feature: Specific functionality in the software that comes together to achieve an outcome.
Want to learn more about SaaS solutions for regulatory information management? Contact us to schedule a custom demonstration.
Global strategy for Unique Device Identifier (UDI) data
The International Medical Device Regulators Forum (IMDRF) developed a UDI framework for a globally harmonized system for the identification of medical devices. Adopted in principle by regulatory authorities in many countries, the implementation of UDI regulations and supporting databases is at varying stages of implementation across the globe.
UDI Components
Establishing a UDI strategy involves understanding requirements for both labeling and regulatory database reporting in each country in which your devices will be marketed.
UDI labeling
The UDI is typically presented as a barcode label on device packaging or the device itself (depending on specific requirements). The UDI consists of two major components:
- UDI-DI - This is the static portion of the UDI which identifies the manufacturer along with the specific device version. The UDI-DI (device identifier) is assigned by an approved organization, such as GS1, and contains a company prefix and the manufacturer's internal product code. The UDI-DI is the primary identifier to be used in looking up device attributes in country-specific databases and is assigned prior to placing a product on the market.
As GS1 is widely recognized as an issuing agency across global regulators and industry, the UDI-DI is often referred to in the GS1 nomenclature of Global Trade Item Number (GTIN). - UDI-PI - This is the dynamic portion of the UDI which is assigned by the manufacturer and identifies a manufacturer’s lot number, serial number, manufacturing date, expiration date, or other data as required. The UDI-PI actual values do not appear in country-specific UDI databases, but these databases often require information about the type of data that the UDI-PI represents on the device label.
UDI regulatory database requirements
Many countries have established, or are in the process of establishing, databases to store UDI data. In the United States, use of the Global Unique Device Identification Database (GUDID) is mandated for medical devices. In the EU, EUDAMED consists of multiple modules with one specifically established for UDI. The UDI module is currently available for voluntary use, with mandated compliance scaled in transitional periods through 2026.
Currently, the US GUDID database provides for machine-to-machine (M2M) transmission of data, allowing manufacturers to upload product UDI data directly into the database. The EU has established requirements for M2M transmission as well, but these requirements are not finalized. Most other countries do not have M2M capabilities at this time.
Universal UDI ®
While each country defines specific UDI data requirements, there is a core set of data that is consistent across many markets. At Rimsys, we refer to this data as the Universal UDI® data. Storing Universal UDI® data separately from any country-specific UDI data is an important data management strategy. This ensures that data is single-sourced and consistently applied across submissions to regulatory UDI databases and in other locations in the manufacturers’ quality management system where the data may be needed.
When storing UDI data locally, consider that the same information may be required in different formats in different country regulatory databases. Currently, Rimsys supports the specific data requirements of the US, EU, Saudi Arabia, China, South Korea, and Singapore. Additional countries, which are expected to have similar IMDRF style requirements, will be added as those databases are established by regulators and brought to the industry. Some examples of these countries are Australia, Switzerland, UK, Brazil, and India.
Note that outside of the US’s GUDID, UDI databases are in flux in most countries. This means that having a central RIM system to track known and well-established UDI data is increasingly important.
Machine to machine transmission of UDI data
Machine to machine (M2M) transmission is the process in which data is transmitted from a company’s internal database, typically a RIM or PIM/PLM system, to the regulatory UDI database. Currently, the GUDID database in the US is the only database for which machine to machine (M2M) transmission has been fully developed and is fully supported. Rimsys offers M2M data transmission for GUDID and is currently working to establish M2M transmission with EUDAMED.
Synchronizing UDI data
It is important to note that there are really no requirements for a medical device manufacturer to keep a quality record of the UDI data submitted to regulatory databases (the official data of record is the data that has been reported to and is retrievable from the regulatory database). This means that it is up to the manufacturer to declare the actual source of data for the quality system and to ensure that data is in sync where required.
One of the strategies that can be used when implementing a new RIM system, such as Rimsys, is to export data from GUDID, EUDAMED, and other regulatory UDI databases. That data then forms the basis for the UDI data that is input into the RIM system, ensuring consistency in the application of data across other countries’ UDI databases.
Maintaining and updating submitted UDI data
It is important to implement procedures to ensure data in a product’s UDI record is consistently applied throughout your internal systems as well as with the various regulatory databases. While a single data point should be stored in as few places as possible, everything should be done to minimize the chances that data will get out of sync.
Any product data changes must be evaluated for, among other things, the effect on existing UDI data submissions to regulators. The data changes must be evaluated to determine if the UDI-relevant data can be updated in impacted regulatory databases or if an entirely new UDI-DI and record must be reported. In some cases, such as a change to the product’s catalog number or contact phone number, an existing UDI record may simply need an update. In other cases, such as a change to the sterilization requirements, a new UDI-DI and a new record may be required.
EUDAMED considerations
The EUDAMED database and M2M requirements for UDI are still not finalized, but they are much more static than they were even a month or two ago. We believe that it is beneficial for medical device manufacturers to establish and organize the data needed to submit their products to EUDAMED as soon as possible.
Legacy devices are those medical devices and In Vitro Diagnostic (IVD) devices that are compliant to previous directives (MDD, AIMDD, IVDD) that are being placed on the EU market under the allowed transitional period. With the compulsory application of EUDAMED identified in the 2026 timeframe and the expiry of the transitional period in 2024, there was no need for manufacturers to register legacy devices in the EUDAMED system. Today, with the extension of the transitional period for the certification of devices under MDR and IVDR through 2027, legacy devices may now again be subject to submission of UDI data in EUDAMED.
There will be a 24-month transition period for manufacturers to apply UDI data to EUDAMED once all modules go live. However, if you have any type of action requiring interaction with the Vigilance module of EUDAMED, the required UDI information for those devices must be present in EUDAMED prior to that interaction. The Vigilance module is intended to manage all types of vigilance reports, including Manufacturer’s Incident Reports (MIR) and Field Safety Corrective Action (FSCA) reporting. This also includes and requires post market surveillance reporting submission to the Vigilance module such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR).
Manufacturers may be surprised with a shortened transitional period for compliance to EUDAMED’s UDI module due to this requirement and should place priority on higher-risk devices due to the increased likelihood of an interaction with EUDAMED’s Vigilance Module.
For additional resources, watch a replay of our webinar, Why UDI is a regulatory concern, not just an operation process - or read our eBooks, The Ultimate Guide to EU MDR/IVDR UDI and The China NMPA UDI System.
Educational resources for medtech regulatory affairs professionals
Staying on top of changing regulations and expectations is challenging for MedTech regulatory professionals around the world. The following list is some of the educational resources that are most used by RA teams to stay current. With the exception of RAPS, we focused primarily on resources provided by regulatory agencies directly. Rimsys does not endorse or validate information on these sites.
Professional Organizations
Regulatory professional organizations provide a combination of free and paid training courses and certifications.
RAPS
The Regulatory Affairs Professionals Society (RAPS) is the first stop for most regulatory professionals looking for education and certification:
- Courses (open to non-members) - includes RAC exam prep, online courses, webinar replays, and training bundles
- Learning portal (RAPS members only)
- Connect RAPS (RAPS members only forum)
TOPRA
TOPRA is a professional membership organization for individuals working in healthcare regulatory affairs. TOPRA was founded in the United Kingdom and is active in Europe.
Regulatory Agencies
United States (FDA)
The FDA offers a variety of free educational resources, including live and on-demand webinars, along with written documentation:
- Training and Continuous Education home page
- Continuing education programs
- CDRH Learn
- Guidance Webinars
EU Medical Devices Sector
- Event list (including educational webinars)
- Publications (including step-by-step guides)
- EUDAMED information center
Canada
- e-Learning courses on how medical devices are regulated in Canada
Singapore
While these are not training modules, the following free “tools” are available from the Singapore Health Sciences Authority:
- Is it a medical device?
Answer a series of questions to determine if your device is considered a medical device in Singapore. - Risk classification tool
Answer a series of questions to determine the risk classification of your medical device. - Registration and licensing requirements
Answer a series of questions to determine the correct registration route. - Medical device grouping tool
Answer a series of questions to determine if you can group your medical devices together for registration.
Additional third-party resources
Some sites that we find particularly useful. Note that Rimsys has no business relationship with these sites.
Paid Resources
Notified Bodies and other large consulting firms can provide detailed training options, but these organizations are in the business of providing expert consulting and education, so these options are not free. Those listed here provide individual, self-service, training courses that are charged per-session:
If you have any additional resources that you think we should include here, please connect with us on LinkedIn or Twitter!
FDA predicate devices
Medical device manufacturers seeking to place a new device in the U.S. market through a 510(k) submission are required to identify a legally marketed device that is substantially equivalent to the new device – i.e.: the predicate device. Selecting the correct predicate device is extremely important in ensuring the success of your 510(k) submission. New devices without a predicate are automatically classified as Class III devices requiring a premarket authorization (PMA) submission (although those with a lower risk profile can apply for reclassification through a De Novo request).
Predicate device requirements
A predicate device is used in a 510(k) submission to demonstrate that the new device to be marketed is safe and effective. This is done through establishing substantial equivalence between the predicate device and the new device. The predicate device must be a legally marketed device approved through a 510(k) submission, to which equivalence can be demonstrated. In identifying a predicate device, preference should be given to devices which are currently marketed in the U.S. and which have received 510(k) clearance relatively recently.
Predicate devices may be:
- Postamendments devices – devices marketed after May 28, 1976. The majority of 510(k) submissions claim substantial equivalence to a postamendment device.
- Preamendments devices – devices which were legally marketed in the U.S. before May 28, 1976 and which have NOT been significantly modified and for which a regulation requiring a PMA application has not been published by the FDA.
- Either postamendment or preamendment devices which are no longer marketed in the U.S. In this case, the predicate device cannot be a device that is, or was, in violation of the FD&C act.
Substantial equivalence
A medical device is considered substantially equivalent to an identified predicate device if the devices share an intended use and meet either one of the following:
- Shared technological characteristics, OR
- Different technological characteristics that do not raise different questions of safety and effectiveness and the safety and effectiveness of the device is demonstrated by information submitted to the FDA.
It is also important that the predicate device selected does not use outdated or superseded technology, which means that newer devices tend to be used as predicate devices. Note that while substantial equivalence needs to be demonstrated, the devices do not need to be identical. However, if the FDA finds that substantial equivalence has not been demonstrated with the identified predicate device, the applicant may:
- Resubmit the 510(k) with new data
- Request a Class I or Class II designation through the De Novo classification process
- File a reclassification petition
- Submit a premarket approval application (PMA)
How to find a predicate device
The FDA provides a 510(k) database containing all devices cleared through the 510(k) process. This database is updated monthly and can be filtered by device class, product code, applicant name, and other information.
Before searching the 510(k) database, the device and product classifications should be determined. The best way to find the correct classification of a new device is to use the Product Classification database, which can be filtered by device name and review panel, along with submission type, product code, device class and more. Searching the 510(k) database with the correct 3-letter product code is typically the most effective way of finding potential predicate devices.
Using a reference device in a 510(k) submission
The identification of a “reference device,” in addition to a primary predicate device, can be used to “support scientific methodology or standard reference values.” A reference device cannot be used in lieu of a primary predicate device and the FDA will evaluate the appropriateness of the reference device.
Note that prior to a 2014 guidance, the FDA allowed for “split predicates,” or the use of one predicate device to demonstrate equivalence in intended use, and another to demonstrate equivalence in technological characteristics. The current guidance finds the use of split predicates "inconsistent with the 510(k) regulatory standard.”
The importance of selecting the right predicate device
Selecting the right predicate device is critical to ensuring that your device can be brought to market through the 510(k) pathway. Selecting the wrong device will result in delays to the regulatory approval process. If an applicable device with current technology cannot be identified, other pathways, including De Novo request and PMA submissions, should be considered. For additional information, read The Beginner's Guide to the FDA 510(k).
