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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.
An overview of 21 CFR Part 820 - quality systems for medical device manufacturers
What is 21 CFR Part 820?
21 CFR 820 is the FDA federal regulation that pertains to quality systems for medical device manufacturers, and it is part of the agency’s set of Current Good Manufacturing Practices (CGMP) for industry. Also referred to as the FDA’s quality system regulation (QSR), the regulation defines design controls and quality processes at all stages of device development in order to ensure that all medical devices marketed in the United States are safe and effective.
21 CFR 820 consists of 15 subparts, which define quality system requirements for each stage and function within the medical device manufacturing process. We define each subpart below.
Federal regulations are organized as Title → Chapter → Subchapter → Part, which means that 21 CFR 820 is short-hand for:
21 CFR 820 vs ISO 13485
ISO 13485 is the de facto international quality system standard for medical device manufacturers, but this is not currently the standard in the United States. While Part 820 and ISO 13485 are structured differently, they have no conflicting requirements. Therefore, companies that are marketing medical devices in the U.S. and in other markets will need to comply with both ISO 13485 and the FDA’s QSR, as defined in 21 CFR 820.
However, the FDA is moving towards harmonizing these standards, and on February 23, 2022 issued a proposed rule to amend the QSR to align more closely with the international consensus standard for Quality Management Systems, primarily by incorporating reference to the ISO 13485 standard. The FDA has published FAQ’s about the proposed rule.
21 CFR Part 820 Requirements
Part 820: General Controls (subpart A)
The General Controls subpart contains three sections providing general information about the regulation, including the scope and applicability along with key definitions.
Scope
The regulation defines current good manufacturing practice (CGMP) requirements governing the methods, facilities, and controls used for the “design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use." Specifically, this subpart defines:
- Applicability:
The requirements of this regulation are intended to ensure the safety and efficacy of all finished medical devices intended for human use that are manufactured in or imported into the United States. Manufacturers that are involved in some, but not all, manufacturing operations should comply with those requirements that are applicable to the functions they are performing.
Exceptions:
- This regulation does not apply to manufacturers of medical device components, but such manufacturers are encouraged to use this regulation as guidance.
- Class I medical devices are exempt from the Design Controls defined in this regulation, except for those listed in § 820.30(a)(2).
- Manufacturers of blood and blood components are not subject to this regulation but are subject to Biologics good manufacturing practices as defined in Subchapter F, Part 606 of the regulation.
Definitions
This section of the regulation contains definitions for a number of terms used throughout the document. The following are the major definitions related to quality records:
- Design history file (DHF): A compilation of records that describes the design history of a finished device.
- Design input: The physical and performance requirements of a device that are used as a basis for device design.
- Design output: The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
- Device history record (DHR): A compilation of records containing the production history of a finished device.
- Device master record (DMR): A compilation of records containing the procedures and specifications for a finished device.
Quality System
The section of the regulation sets the basic requirement for a quality system by stating that “Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.”
The term “appropriate” is used throughout this regulation and can be open to interpretation. A manufacturer, however, should assume that all requirements are appropriate and applicable except in cases where non-implementation of the requirement can be shown to have no effect on the product's specified requirements or ability to carry out necessary corrective actions.
Quality system requirements (subpart B)
This section of the regulation defines the overall responsibilities and the resources required for the management of the quality system.
Management responsibilities
Executive management is responsible for establishing a quality policy and ensuring adequate resources to effectively maintain and manage the quality system. In addition, management is responsible for establishing a specific quality plan, consisting of relevant practices, resources, activities, and procedures.
Quality audit
Periodic audits of the quality system are required to be conducted by personnel not directly responsible for the activities being audited. The dates and results of each audit need to be documented, along with the results of the audit. It is expected that corrective actions and, when necessary, reaudits, be performed for any identified noncompliances.
Personnel
Manufacturers are responsible for assigning sufficient personnel with appropriate experience and training to perform all tasks required by the quality system plan.
Design controls (subpart C)
Manufacturers of all class II and class III medical devices, along with the specific class I devices listed in paragraph (a)(2) of this regulation, are required to establish design control procedures that ensure design requirements are met as specified.
Design controls shall define:
- Design and development planning - Plans that describe the design and development activities, and responsibilities for these activities and their implementation.
- Design input - Procedures that ensure design requirements are appropriate and address the intended use of the device.
- Design output - Procedures that document design output, including acceptance criteria, so that conformance to design input requirements can be adequately evaluated.
- Design review - Formal and documented reviews of the ensign results that include participation from representatives of all.
- Design verification - Procedures for verifying the device design that confirm that the design output meets the design input requirements.
- Design validation - Procedures for validating the device design, ensuring that devices conform to defined user needs and intended uses, and including testing of production units under actual or simulated conditions.
- Design transfer - Procedures to ensure that the device design is correctly translated into production specification.
- Design changes - Procedures for identifying, documenting, validating, and managing the verification and approval process of all design changes before they are implemented.
- Design history file - A design history file (DHF) is required for each type of device and should include or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and device requirements.
Document controls (subpart D)
Medical device manufacturers are required to put in place document controls for all documents required in this regulation.
Document approval and distribution
One or more people must be assigned to review and approve documents prior to issuance. The approval must be documented, include a date and the signature of the approver, and be made available at all locations where applicable. Procedures must also be in place to ensure that obsolete documents are removed and/or prevented from being used.
Document changes
Similar to document approval procedures, changes to documents must be approved, reviewed, and documented. Records of all changes must be maintained.
Purchasing controls (subpart E)
To continue reading this Regulatory Brief, including a definition of the remaining subparts and a comparison of 21 CFR 820 to ISO 13485, please download the full brief.
CE marking guide for medical devices in the EU
This article is an excerpt from the CE marking guide for medical devices in the European Union.
Table of Contents
- What is CE marking?
- Why is CE marking important?
- CE marking responsibilities
- What countries require or accept CE marking?
- Which medical devices require a CE mark?
- Technical documentation
- What are the costs associated with CE marking?
- How do you apply the CE marking?
- CE mark and UDI
- Does the CE mark expire?
- Do I need to CE mark my software?
- Final steps
CE marking is a symbol that consists of “CE, “ which is the abbreviation of the French phrase "Conformité Européene" meaning "European Conformity". The term initially used to describe “CE” was "EC Mark" but it has officially been replaced by "CE marking" according to the EU Directive 93/68/EEC. CE marking is used in all EU official documents, although you will still see "EC Mark" being used in common language. If you are using EC Mark in your documentation, you should change that terminology to CE marking in the future.
The letters ‘CE’ appear on many products traded on the Single Market in all the member states of the European Union plus Iceland, Liechtenstein, Norway and Switzerland. Simply put, The CE mark is a mandatory compliance mark, informing the consumer that the product is compliant with all applicable EU directives and regulations where the CE mark is required.
The Single Market was established in 1993 and is still considered one of the most significant achievements of the European Union. The main goal was to ensure the movement of goods and services freely within all the member states and to establish high safety standards for consumers. The CE mark indicates that goods and services do not need to be verified when shipping into another member country. To further support this movement, in April 2011, the Single Market Act was established to boost growth and strengthen confidence in the economy even further.
CE marking is required for many types of products, not just medical devices. The CE symbol can be found on bicycle helmets, toys, laptop batteries, wheelchairs, construction equipment, gas appliances and cell phone chargers - to name a few. CE marking is required for products manufactured anywhere that are sold in the EU, and only for those products for which EU specifications exist and require CE marking. The CE marking signifies that the product has been found to meet the general safety and performance requirements (GSPRs) of the European health, safety and environmental protection legislation and allows the product to be sold in the EU.
Manufacturer responsibilities for CE marking
Medical device manufacturers are responsible for properly and legally CE marking products before they leave the warehouse.
Most Class II and III medical devices, along with IVDs and some Class I devices, require a conformity assessment performed by a Notified Body to ensure that all legislative requirements are met before it can be placed on the market. Manufacturers of most Class I devices can self assess conformity. This process needs to demonstrate that all the legislative requirements are met, including any testing and inspections, and that all necessary certifications are obtained.
The European Commission lists 6 steps that manufactures should follow to affix a CE marking to their devices:
- Identify the applicable directive(s) and harmonized standards - see EU standards for Medical Devices, In Vitro Diagnostic (IVD) devices, and Implantable Medical Devices.
- Verify product specific requirements using the essential principles identified in the above standards.
- Identify whether an independent conformity assessment by a Notified Body is necessary. Notified bodies will be required to verify compliance with relevant Essential Requirements for most medical devices classified as IIa, IIb, or III - along with sterile class I devices. See the Notified and Designated Organization (NANDO) database for available notified bodies.
- Test the product and check its conformity.
- Create and keep available the required technical documentation.
- Affix the CE marking and create the EU Declaration of Conformity.
Importer responsibilities for CE marking
If you are importing medical devices into the EU, it is your responsibility to review all the technical documentation and maintain a copy, or to make sure that it’s available to you upon request.
You should verify:
- That the device has been CE marked and that the EU declaration of conformity has been completed.
- That the manufacturer has designated and established an authorized representative.
- That the device is labeled appropriately and contains instructions for use (IFU).
- When applicable, that a UDI has been assigned to the product.
- Whether or not the product is registered in EUDAMED (registration is currently voluntary).
Take action:
- List your name and address on the device or packaging, in addition to the manufacturer’s information.
- Keep records of complaints, non-conformities, recalls, etc. on file.
- Report any noticed non-conformity or product complaints from end users to the manufacturer and authorized representative immediately.
- Maintain a copy of the EU declaration of conformity and any other relevant certificates.
Distributor responsibilities for CE marking
If you are a distributor, you are responsible for reviewing the technical documentation provided to you so that you can verify the product is safe to put on the local market. You must also be sure the product is labeled correctly with the CE marking symbol clearly visible. The technical file documentation contains all of the information that is necessary to show conformity of the product to the applicable requirements.
You should verify:
- That the device has been CE marked and that the EU declaration of conformity has been completed.
- That the device includes all the appropriate labeling, including instructions for use.
- That if imported, the importer has complied with all the EU regulations.
- When applicable, that a UDI has been assigned to the product.
Take action:
- Report any noticed non-conformity to the manufacturer, importer, and authorized representative immediately.
- If a product appears to be out of compliance to the regulations and could pose a serious risk, the information should be reported to the Competent Authority, and to the manufacturer, importer and authorized representative.
- Any complaints or reports from end users about the product should be reported to the manufacturer and, if necessary, to the importer and authorized representative.
Important note: If the importer or distributor markets the product under their own company name, then they become responsible for CE marketing, and take over that role from the manufacturer.
CE marking is mandatory when importing products into the European Union, which is part of the larger European Economic Area (EEA). The EEA Agreement, established in 1992 and made official in 1994, is an international agreement that enables the extension of the European Union’s single market to non-EU members. It consists of the 27 EU countries plus the four European Free Trade Association (EFTA) countries - Iceland, Liechtenstein, Norway and Switzerland. Today, the EFTA has 29 Free Trade Agreements (FTAs) with 40 countries and territories outside the EU. Because these countries operate in the single market, this allows free movement of goods and services across all of the EEA.
Source: European Environment Agency (EEA).
All medical devices sold in the EU require a CE mark. While a CE mark is not required for items such as chemicals and pharmaceuticals, it can be required for combination devices and medical device software. For these two situations, how do you know if your product requires a CE mark?
To continue reading this ebook, including an overview of CE mark costs, and the associated technical documentation/general safety and performance requirements (GSPRs) that manufacturers are required to maintain please register to download the full version
Dispatches from RAPS Convergence: The state of regulatory tools
A few weeks ago we attended (virtually) the RAPS Euro Convergence conference. The event, despite the virtual format, still brought together regulatory professionals from across the European region for several days of immersive learning. At Rimsys, we took advantage of the opportunity to explore the state of regulatory tools and processes in the region, and see how they compare to those of North American teams.
Visitors to the Rimsys booth, both at RAPS Euro Convergence and at last year’s North American RAPS Convergence event were invited to fill out a short survey in exchange for the opportunity to win an Amazon gift card. While the respondents were self-selected, and the results aren’t statistically significant, they still showcase some interesting differences in the tools and mindset of regulatory affairs professionals in each region.
Regulatory tools used
Across both regions, Excel is the most commonly used tool by regulatory teams. Over half of respondents across both regions reported using Excel to manage regulatory information and processes. European regulatory affairs professionals were much more likely to use an electronic quality management system (eQMS) to manage their work, and about one-third of respondents to both surveys indicated that they used physical paper-based documents.
We also asked respondents how well their tools were working. European respondents were generally more content with their toolset with 66% saying their tools were “good”. By comparison only 22% of North American respondents felt the same. One thing that was clear was the impact of paper-based processes on satisfaction. Respondents who reported struggling with their current tools were nearly twice as likely to use paper-based processes as part of their regulatory activities.
Work efficiency and satisfaction
Just over 50% of all respondents indicated that the tools they use “could be better”. This may have something to do with the amount of manual work that RA teams find themselves doing. As part of the survey we asked respondents how many hours it takes on average for them to update one of their Essential Principles / General Safety and Performance Requirements (GSPR) tables. The most common response from the EU event was 3-7 days, while those at the North American event were most likely to report greater than 7 days for the same task.
Given their slightly better estimated performance when it comes to regulatory processes, respondents from the EU were less likely to express frustration with their roles and dissatisfaction with their productivity. We asked attendees at both conferences to rate their “regulatory frustration” and satisfaction with their productivity on a scale from 1 to 5 with 1 being very frustrated/unsatisfied, and 5 being very satisfied/not frustrated at all.
EU respondents were noticeably more positive in their assessments than our North American respondents, although everyone generally had a favorable view of their productivity.
Implications
Looking at the survey results, there are some interesting discrepancies. Teams in both regions heavily use poorly-suited tools and manual approaches to regulatory processes, yet have generally favorable views of their productivity. This points to two likely conclusions. One, that regulatory affairs professionals are particularly comfortable with a lot of manual administrative work, and two, that they’re largely unaware of the new class of regulatory information management (RIM) solutions that are specifically designed to automate and streamline regulatory workflows.
RIM platforms (like Rimsys) provide a digitized central repository for regulatory information and content, allowing RA professionals to streamline product submission, authorization, and maintenance processes (such as updating GSPR tables that we discussed earlier). RIM platforms can reduce the time and resources required to complete regulatory activities by more than 50%.
Building a business case for a RIM system
While the space is growing quickly, regulatory information management (RIM) systems are still relatively new to a lot of medtech companies. RIM systems help companies digitize and automate regulatory activities associated with their products. They provide a central information repository for all regulatory content and streamline activities like market registrations, data capture and transmission of unique device identification (UDI), and building essential principles tables while tracking associated standards.
Given that many regulatory affairs teams still manually manage these processes through complex spreadsheets and disjointed documents, the value of an automated solution is pretty obvious, but quantifying that value—especially for teams that aren’t seasoned software acquirers—can be a bit harder. This guide provides a framework for regulatory affairs teams to quantify the potential benefits of a RIM system, and build an internal business case for investment.
Challenges with the traditional approach to regulatory affairs
While functional, there are a number of painful inefficiencies that come along with traditional approaches to regulatory processes. Without an automated way to keep track of all the information and supporting documents associated with these processes, companies struggle with:
- Lack of visibility into regulatory data, clearance/approval status for different markets, and time-to-market metrics
- Compliance gaps driven by disconnects between go-to-market, distribution, and regulatory affairs teams
- Difficulty assessing the impact of, and responding to changes in standards or regulations
- Accumulation of “tribal” knowledge among individuals that limits continuity and visibility across the organization
These pains represent specific costs to MedTech companies in the form of:
- Staffing: Companies must over-staff regulatory affairs teams to support highly-manual processes. Expensive consultants are often brought in to help address in-house resource shortages.
- Productivity: Regulatory affairs teams lose huge amounts of time repeatedly hunting for information (up to 50% of their time spent).
- Lost revenue: Long application times and lack of process visibility delay market entry for new products. Non-compliance can lead to fines, or the need to pull products out of specific markets.
The automation and data consolidation/integration provided by a RIM system can significantly reduce these costs, and provide a clear, measurable return on investment.
Additional benefits of a RIM system
In addition to the addressing the pains outlined above, RIM systems can provide valuable benefits across MedTech companies:
- IT teams: Without a bespoke platform to manage regulatory processes, regulatory affairs teams rely on a broad collection of tools to support their day-to-day work. This can include specific software to create and manage UDIs and access regulatory intelligence, as well as use of software designed for other functions: enterprise resource planning (ERP), product lifecycle management (PLM), or quality management systems (QMS)—highly-configured to try and support regulatory activities. A comprehensive RIM system (like Rimsys) provides support for multiple regulatory functions, saving IT teams the cost of acquiring and maintaining separate systems. With functionality specifically designed for regulatory processes, a RIM system is easier to support than customizations to tools designed for other functions.
- Go-to-market teams: Sales and marketing organizations can also benefit from the adoption of a RIM system. In addition to bringing new solutions to market more quickly, RIM systems can also help with planning and forecasting. Visibility into the time and cost required to enter different markets, and the specific regulations associated with each market, can help go-to-market teams better prioritize target markets, and set revenue projections for their product lines. RIM systems can also provide workflows for project requests, allowing go-to-market teams to better coordinate registrations to support planned product launches.
- Distributors, in-country sponsors, and notified bodies: One-off email communications with external parties is not only time consuming for regulatory affairs teams, but inefficient for partners. RIM systems can provide controlled access for external parties, allowing them to login and directly access needed information without sending an email, and waiting (sometimes days) for a response. Streamlining these communications allows partner organizations to move more quickly, and ultimately accelerate the delivery of products into new markets. This helps to grow revenue while also improving the productivity of regulatory affairs teams who no longer have to interrupt their work for every internal or external information request.
Building your business case
Putting together the challenges and benefits outlined in the previous section (as applicable to your team), will feed the primary content of your business case. Next we’ll take a look at how to structure the content.
Part 1 – Your current situation and challenges
One of the best places to start when putting together a business case for a RIM system is to look at your current situation. What are the challenges that your organization faces? How much time is spent looking for information, submitting marketing applications, completing regulatory impact assessments, creating and maintaining the new MDR / IVDR GSPRs? How long does it take your team to complete new registrations? How well do internal teams communicate and coordinate go-to-market activities for new products and markets? How many products and countries does your team support today? What would happen if that number increased significantly?
Next, look at the business implications of the current situation. Does your team have a backlog of requests from go-to-market or other management teams? How often do you bring in external consultants to help with workload? Note the associated costs of your project backlog (delays in receiving market clearance), and the amount spent each year on consultants. Are there any other business risks such as continuity or non-compliance that are associated with your current approach? Does your team have the ability to identify regulatory roadblocks associated with markets you’re planning to enter?
Part 2 – Recommended solution
Here’s where you make the primary case for a RIM system. Highlight the specific capabilities and benefits of your solution of choice, and how it will address the challenges of your current situation. Highlight areas where other teams will benefit from the solution, and opportunities to drive greater organizational alignment.
Part 3 – Costs and expected ROI
Estimating costs and returns can be difficult, but it’s one of the key ways to improve the credibility of your business case. If you’re unsure about costs you can generally assume that a full-featured RIM system will cost the equivalent of 1 to 3 full-time regulatory affairs professionals, and use that as a starting point.
When calculating returns start with time-savings. If regulatory activities could be completed 50% more efficiently, how would that impact the number of consulting hours you use or hiring plans? If you could reduce pre-market clearance time by 6 weeks, how much additional revenue could be generated? Have you had instances where you incurred fines or had to remove products from a market due to compliance issues (i.e. shipping to markets where the product hasn’t been approved)? What were the associated costs?
Next, look at what your RIM system is replacing. Do you have individual tools for UDI or other functions that could be replaced? What about other tools? Does your team have seats in ERP or QMS tools that won’t be needed any more? All of these are relevant cost savings. In most cases, a RIM system will show strong ROI once you’ve estimated all of these savings.
Part 4 – Alternatives
Here’s where you want to demonstrate that you’ve done your due diligence in support of your recommendations. Have you evaluated multiple software solutions? Enumerate the specific capabilities or approach that led you to recommend your preferred vendor. Are there other ways to address your current challenges: expanding the regulatory affairs team, or implementing other types of software (rather than a RIM system)? Explain why you think these solutions will be less effective.
Putting it together
RIM systems can provide significant benefits specifically to regulatory affairs teams and broadly across MedTech companies. With a bit of legwork, it’s easy to put together a compelling case for investment in a solution. What can sometimes lead to difficulty in quantifying potential benefits—the fact that many MedTech companies don’t have a robust measurement framework for Regulatory affairs processes—means that you’ll be in a much better position to assess the performance of your team and impact of your investment once the analysis is complete.
Ready to get started? Download our RIM business case template. Questions? Our team is happy to work through the process with you and validate your estimates based on the experiences of our clients.
5 ways a RIM system can accelerate time-to-market for MedTech companies
Like all products, time-to-market is a critical success factor for medical technology (medtech). Product research and development ties up capital investment that can only be recouped when products start selling. For start-up and early stage companies, time-to-market can be the difference between success and failure. With a limited capital runway, they must demonstrate market success to access additional funding and growth opportunities. Unlike other products, however, medical devices have an added hurdle of regulatory clearance that must be obtained before products can be marketed and sold.
Underestimating the regulatory burden
It’s easy to underestimate the amount of time and effort required for regulatory activities related to New Product Introductions (NPI), especially during the development process. Policies, procedures, and submission processes can vary significantly between countries and regions, and almost all of them require government clearance before devices can be marketed. For larger companies it’s not unusual to operate in 100+ countries, creating an enormous array of standards and applications that must be manually managed.
These challenges are exacerbated by unclear lines of communication and siloed information across systems. Product development and testing information is stored within Product Lifecycle Management (PLM) and Quality Management System (QMS) solutions. Sales forecasting, marketing, and production information is stored within Enterprise Resource Planning (ERP) and Customer Relationship Management (CRM) systems. And regulatory, standards information, and compliance documents are stored across various file systems.
Regulatory submissions must synthesize information from R&D, QA, and go-to-market teams, and data from across all of these systems. Any mis-steps, or missing information can result in significant go-to-market delays, and even rejections from regulatory bodies. Coordinating regulatory status between go-to-market regulatory affairs teams can be a particularly vexing challenge. Without clarity about what markets have been cleared/approved, companies run the risk of moving too quickly ahead of the regulatory process, or unnecessarily delaying market entry.
What is a RIM system?
Despite all of the complexity associated with regulatory submissions, many teams rely on rudimentary approaches to coordinate and manage them. Submissions and associated data are managed via individual documents or complex color-coded spreadsheets, with no central repository of submission records or status.
Regulatory Information Management (RIM) systems are software solutions designed specifically to help companies streamline the submission, authorization, and maintenance process. They provide a digitized central repository for all regulatory information and content, allowing companies to automate and maintain compliance in the global market.
Using a RIM system to manage regulatory submissions and compliance can improve efficiency and productivity, reduce the risk of rejected submissions and noncompliance, and provide greater visibility into ongoing registration processes and status across the organization. While RIM systems provide specific benefits to regulatory affairs teams, they also provide company-wide benefits—specifically when it comes to accelerating time-to-market for new products.
5 ways a RIM system can accelerate time-to-market for new products
Full-featured RIM systems (like Rimsys) provide a number of capabilities that MedTech companies can take advantage of to get new products to market more quickly—and keep them there.
- Regulatory intelligence. Medical device registration requirements and standards vary across regions and countries. Understanding market entry requirements and timelines for regulatory submissions are necessary for any go-to-market planning, but finding and keeping track of this information can be challenging—especially for early-stage companies. RIM systems can provide up-to-date information about regulatory requirements without a lot of manual research and document management. Go-to-market teams can leverage the breadth of regulatory information in the system to develop rollout strategies for different markets, and identify the most attractive markets based on size and regulatory complexity.
- Digital forms and templates. Each regulatory submission requires multiple templates and forms, many of which aren’t available digitally. Finding the correct, current form, and manually filling it for each country/region can add significant time to the regulatory submission process. RIM systems can take the guesswork out of finding forms, by providing a library of digital templates for different markets that companies can easily access and fill. Even offline forms can be loaded into the system for digital filing and storage. With a modern RIM system, regulatory teams can easily access, fill, and track progress for submission forms in all the markets they’re looking to enter.
- Centralized visibility and information storage. RIM systems can function as a “digital hub” and single source of truth for all of the information associated with the regulatory process. Submissions require detailed product information, testing results, labeling, and other information that is often stored in other systems. Rather than sourcing this information over and over again, RIM systems provide regulatory teams with an organized repository that they can reuse across global applications. RIM access can be extended to other teams, and even external partners (like in-country distributors) to provide visibility into regulatory information and the status of submissions, making it easier to drive alignment around the process and coordinate go-to-market plans.
- Process integration across systems. Market authorization is one of the most critical pieces of information that go-to-market teams need. Maintaining that information across multiple products and multiple markets, and keeping it visible to go-to-market teams is a consistent challenge. RIM systems can integrate directly with ERP or CRM systems to feed authorization information directly into sales and distribution processes. Automating the in-country authorizations across systems can prevent noncompliance, and ensure that go-to-market teams are able to launch as soon as authorization is obtained. The same integration capabilities can be used to automatically retrieve product information from PLM and QMS systems, further speeding the application process.
- Automated regulation and standards tracking. This doesn’t necessarily directly impact time-to-market for new products, but it can definitely impact time in the market. Regulations and standards aren’t static, and regulatory affairs teams must keep on top of pending changes to ensure that products remain compliant and retain selling authorization. RIM systems can help to track changes, and flag products for potential compliance issues or that are at risk of losing authorization.In addition to regulatory changes, RIM systems can track authorization expirations, and other important events, helping companies maximize the revenue potential of their products by avoiding regulatory disruptions.
Accelerating regulatory approval and product go-to-market
MedTech companies are keenly aware of the role regulation plays in getting new products to market, but they aren’t always aware of the time and effort required to reach all of their target markets. Manual processes, disjointed information, and lack of coordination and visibility across teams can make it hard to obtain marketing authorization in a timely manner. This can significantly impact time-to-market—delaying return on investment, and even putting companies, themselves at risk.
RIM systems can eliminate a lot of the inefficiencies that slow down regulatory processes. By providing insight into regulatory requirements, access to digital templates, and integration across tools, they make it easier for companies to complete timely, successful regulatory submissions, and accelerate time-to-market.
RIM software from Rimsys
Rimsys is the only holistic RIM software designed specifically for medical technology companies. It helps companies digitize regulatory management by bringing together global UDI requirements, Essential Principles/GSPR, and regulatory registrations while monitoring products at the SKU level.
To learn more about RIM software from Rimsys, read our benefits datasheet.
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Foster City, Calif., January 12, 2021 – Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc., a world-leading provider of a holistic Regulatory Information Management (RIM) software platform designed specifically for medical technology (medtech) companies.
The Arena and Rimsys partnership offers a secure cloud-based, product-centric regulatory solution for the medtech industry. Rimsys seamlessly integrates with Arena’s QMS and PLM solutions by pulling product and documentation information directly into Rimsys to create, manage, and maintain marketing applications such as 510(k), Summary Technical Documentation (STED), and Table of Contents (ToCs).
The Arena product development platform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsys integrates with Arena’s platform by syncing product information so companies can better manage global registrations and selling status at the SKU level. Rimsys has the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitors for documentation changes and alerts users when updates occur with additional reporting based on document location ensuring a single and accurate source of truth.
"The seamless and deep integration between Rimsys and Arena solutions reduces the day-to-day regulatory management," said James Gianoutsos, Founder and President of Rimsys. "The administrative burden of compiling marketing applications and the maintenance of product data is completely eliminated, allowing for increased compliance, efficiency, and visibility throughout the organization."
"Our partnership with Rimsys makes it easier for MedTech companies to address regulatory affairs, product registration, and standards management more effectively," said George Lewis, VP of Business Development and Strategy for Arena Solutions. "This new integration streamlines regulatory compliance processes by accelerating the notification of updates to critical quality records and documents."
About Arena Solutions
Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
About Rimsys
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. Built by and for regulatory affairs professionals, Rimsys digitizes, automates, and creates regulatory order to ensure products adhere to changing global regulations. It is the only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software that makes it easy to manage global UDI requirements and navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence. rimsys.io
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated solution to address the global Unique Device Identification (UDI) requirements. This enhancement to the Rimsys ecosystem is immediately available to new and existing customers, providing a compliant method for tracking and traceability of UDI data that is fully compatible with global health authority databases.
UDI is a global harmonization effort to provide more consistent data that benefits overall product traceability throughout the medical device supply chain. It aims to adequately identify medical devices from manufacturing through distribution to patient use. Because global markets have different UDI requirements, product data can become a maintenance nightmare, even for the most mature medical technology companies. Data management is further complicated as UDI data is not static and must be updated based on changing regulatory requirements, such as market dates and registration status.
"Rimsys is the first automated UDI solution to fully integrate into a product’s registration lifecycle, ensuring that changing regulatory information is properly captured, registered, and maintained with the product and within government UDI databases like the GUDID (USA) and EUDAMED (EU)," said James Gianoutsos, Founder & President at Rimsys, "The current solutions landscape revolves around creating in-house, custom, and expensive projects with custom-built software or existing ERP software that were not designed to keep up with the fast-paced and ever-changing regulatory landscape."
In order to stay compliant and competitive, medical technology companies need to adapt quickly and flawlessly to the regulatory environment. As UDI requirements are rolled out across the globe, Rimsys’ UDI module seamlessly integrates with product registration data that is already actively managed within Rimsys, resulting in less maintenance, reduced costs, better compliance, and ultimately decreased time-to-market.
"We have already seen how our system has helped world-leading medical technology companies, such as Johnson & Johnson, Omron, and Terumo, digitize, automate, and navigate the global regulatory landscape,” said Brad Ryba, Chief Technology Officer at Rimsys, "As these requirements and demands continue to evolve, we are committed to ensuring that regulatory professionals can leverage the data integrations within Rimsys to more proactively manage their regulatory information."
Interested customers can schedule a preview of the new UDI module.
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys has been named a Finalist in Tech 50’s 2020 awards program hosted by the Pittsburgh Technology Council. The awards program, which was held November 12, 2020 at a virtual gala event, announced the winners and finalists. Rimsys was nominated as Innovator of the Year in the MedTech category, along with Sentact, Philips, and TeleTracking Technologies. In addition to the Company’s nomination, Rimsys’ Founder and CEO, James Gianoutsos, was nominated for CEO of the Year.
The awards program honors technology innovation in the region. Rimsys Inc., provider of the only holistic Regulatory Information Management (RIM) software for medtech is headquartered in Pittsburgh, Pennsylvania and was proud to be among the 2020 nominees. Rimsys was named a finalist this year, as Sentact, a provider of healthcare technology solutions for the patient care journey, walked away as the winner. Barbara VanKirk, CEO of IQ Inc., won this year’s CEO of the Year award.
"Rimsys is honored to be a finalist in both categories. Thank you to the Pittsburgh Technology Council for highlighting all of these innovative companies, and congratulations to this year’s winners," said Gianoutsos, "Rimsys is already used and trusted by leading companies, including Johnson & Johnson and Terumo, and we look forward to the near future where Rimsys’ automation of the global regulatory landscape is commonplace for medical technology companies and regulatory affairs professionals."
James Gianoutsos founded Rimsys in 2017, recognizing that while regulatory management platforms existed for pharmaceutical companies, medical technology companies face an entirely different set of challenges and requirements. Equipped with the expertise and drive to give regulatory affairs professionals a better way, he developed Rimsys: a RIM software built 100% for medtech companies.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. Its newest integrated module manages global UDI requirements.
"It’s been an unparalleled year with unthinkable challenges," said Audrey Russo, President & CEO of the Pittsburgh Technology Council, "The COVID-19 Pandemic has tested everyone’s mettle in ways never imagined. This year’s Tech 50 is a testament to the fortitude, creativity, and innovation that exists across our industry, membership, and in every Tech 50 winner and finalist."
For a full list of finalists and winners, visit the Pittsburgh Technology Council’s website.
