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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.
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 The term initially used to describe “CE” was "EC Mark" but it has officially been replaced by "CE marking" according to the EU Directive 93/68/EEC.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
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.
Rimsys secures $1.5 million to accelerate growth of its leading medtech regulatory information management platform
Rimsys Inc., provider of the leading Regulatory Information Management (“RIM”) software designed specifically for medical technology (“medtech”) companies, announced today it closed a $1.5 million investment round, led by Allos Ventures. The financing round will support Rimsys’ penetration of the medtech RIM market through planned expansions of its product offering, sales, and marketing execution. Rimsys serves an expanding list of enterprise customers, including industry leaders such as Johnson & Johnson and Terumo.
"Complex regulatory challenges create barriers that delay product time-to-market, stall revenue growth and increase exposure to compliance risks for even the most experienced medtech companies," said James Gianoutsos, founder & president of Rimsys. "Regulatory teams are in need of digital solutions that provide more efficient and compliant ways to stay on top of a constantly changing regulatory environment"
Rimsys’ solution seamlessly integrates with medtech manufacturers’ existing quality management systems, product lifecycle management systems, and sales and distribution software systems. Rimsys’ robust digital platform, with its intuitive user interface and global intelligence, enables its customers to meet market entrance requirements and grow internationally. John McIlwraith, managing director at Allos Ventures will join Rimsys’ board of directors.
"The maze of global regulations covering medical technology is growing more complex and frequently results in dead ends and delays that can greatly impact commercialization of these products," said McIlwraith. "This financing round will enable the company to further accelerate its momentum with large enterprise customers."
For more information on Rimsys, please visit www.rimsys.io.
Rimsys announces new brand identity for world-leading regulatory information management (RIM) software
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced a new brand identity and tagline. Rimsys, the only holistic RIM software on the market designed specifically for medical technology companies, with functionality for the pillars of regulatory affairs, rebranded to accurately reflect its novel and advanced offering through a distinct, modern brand identity and messaging platform.
The new visual identity, including logo, color palette, graphic elements, and iconography mirror the trusted, relatable, and modern personality of Rimsys. The colors, which feature a vibrant purple and dark blue, were strategically chosen to differentiate Rimsys from other RIM solutions on the market. The visuals are accompanied by a new mission statement, “to digitize, automate, and create regulatory order for the medical technology industry,” and messaging platform that conveys its value propositions:
- Used and trusted by the world’s leading medtech companies
- Built by and for regulatory affairs professionals in medtech
- Easy to start and simple to scale as your company grows
"We’re pleased to announce this rebrand to our customers and partners, with complete confidence that the new identity and messaging accurately reflect our enterprise software solution," said James Gianoutsos, Founder & President at Rimsys.
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. These functions, plus soon-to-be-released features, were formally messaged in the rebrand, including superior server security, system compliance, and simple integrations with many leading enterprise QMS and ERP/PLM software systems.
"With successful implementations in some of the world’s leading medical technology companies including Johnson & Johnson and Terumo, we already know Rimsys has the power to modernize medtech companies of all sizes and scales," said Gianoutsos. "And now, with a brand that mirrors our capabilities, we’re even better poised to reach out and help more."
Components of the rebrand can be seen on rimsys.io, and the full rebrand will be revealed on a new website that is currently under development.
Announcing the release of Rimsys 3.0: Rimsys Insight
Rimsys Regulatory Management Software, the leading and only Regulatory Information Management (RIM) system platform designed specifically for the medtech industry, has just released Rimsys 3.0, which includes its much anticipated regulatory intelligence module, Rimsys Insight.
Rimsys 3.0 now offers curated regulatory news along with changes to laws, regulations, and guidances that are timely and linked to customers’ specific products, markets and the other customizable filters available to each company. Additionally, the integration of market entrance requirements for the top 50+ global markets, further strengthen the already powerful Rimsys Registrations workflow which manages medical device and IVD registrations at the SKU level.
"Information is meaningless unless you can apply context to it as it relates to your company and products. As regulatory professionals ourselves, we know the specific pain that is experienced by our customers. The user experience should be seamless, fully integrated, and intuitive enough that, regardless of how long that person has been in the industry"
Rimsys was built for and by regulatory affairs professionals, enabling teams to digitize and automate otherwise disjointed, paper-based and manual processes. Rimsys has spent the last year working with customers from some of the world’s leading medical device manufacturers to develop the requirements that seamlessly integrate their business processes with its existing ecosystem of cloud-based regulatory affairs software solutions. This includes global product registrations, submissions management, standards management, essential principles and more.
"There’s simply no other holistic and vertically integrated solution quite like Rimsys out in the marketplace. Our initial features were focused on bringing MedTech companies together to collaborate and connect with each other internally. Built on this solid foundation, our latest release truly empowers and connects them to the entire global regulatory ecosystem"
Rimsys is a holistic approach to modernizing, digitizing and automating regulatory affairs activities for the MedTech industry by providing a single source of truth. Rimsys is now aligned and positioned to continue its growth and mission to "digitize, automate and createregulatory order for the medical technology industry™."
5 signs you are ready to take your medical device regulatory team digital
The medical device industry is in dire need of robust, practical and easy-to-use software to make regulatory professionals’ lives easier. Without a unified, collaborative, and regulatory digital system, serious consequences to a business can occur, including an increased risk of noncompliance, increased costs, and a significant reduction in a product’s revenue potential.
Here are the five biggest indicators that it’s time to take your medical device regulatory team digital.
1. You miss simple regulatory compliance requirements
Has your company missed an update to a standard? When a standard is updated that compliance is claimed for your products, a thorough review and associated gap analysis need to be conducted to determine if there is any impact to your products. You also need to go through every single essential requirements checklist to determine where that standard is referenced and update it throughout. If you miss those activities, you will most likely receive a finding when being audited that will require corrective action and significant resources to fix and ensure it doesn’t happen again.
Additionally, as the new Medical Device Single Audit Program (MDSAP) is rolled out, regulators from different markets are now working together to identify instances of noncompliance as well as misalignment of information in submissions and other communications.
MDSAP requires medical device manufacturers to produce evidence of marketing authorization for each country that they sell into. Your regulatory team needs automation to work for them in a way that creates safeguards to prevent unintentional release of products into markets.
There is a high need for more effective control of the submission process, enabled by a unified platform, which can lead to a leaner, higher quality submission and a reduced regulatory burden.
2. Your revenue is impacted
Are you missing registration dates, experiencing slow-to-market losses or long-term, cascading impacts such as loss of customer loyalty? All of these have an immediate and lasting impact on market capitalization.
If your marketing authorization lapses, your company legally cannot continue to sell within that country or market, guaranteeing your sales team becomes frustrated because they won’t hit their sales numbers and your company’s financial projections will be impacted.
Moreover, improper release of a product due to lack of visibility to regulatory statuses can cause fines and loss of credibility with authorities, which can result in increased scrutiny.
Based on a recent survey of 100 companies, 65% of regulatory professionals require at least a week to gather the information needed to determine where their products are sold and whether they are properly registered within a country or market.
If you can’t easily find the information, how effective and compliant can you really be? It may be time to take your regulatory team digital.
3. You miss your time-to-market targets
How do you organize and manage your regulatory information?
If you immediately thought of SharePoint, Excel, Word, Email, Outlook, or Dropbox, you probably aren’t working in the most efficient manner.
In fact, based on a Deloitte study, up to 50% of a regulatory team member’s time is wasted looking for information. Not only is your process inefficient but the way that you manage data and documents from a regulatory perspective is broken.
Based on FDA’s published data, 35% of all 510(k)s submitted to the FDA get stamped with Refuse to Accept (RTA) designation due to simple and avoidable mistakes.
Avoiding these needless delays in getting your products to market should be a top priority to ensure months or years are not added to getting your product the proper clearances.
4. You are burdened by administrative activities
Are you having trouble with efficiency, collaboration, and talent retention on your regulatory team?
Employee turnover on regulatory teams is linked to stress and increases greatly if team members consider processes to be inefficient or wasteful. Being able to perform one’s job efficiently and the perception of being part of a high-performing organization contributes to employee satisfaction and retention.
Regulatory processes touch multiple functional areas of a business in the highly regulated medical device industry. Regulatory teams have been piecing together disparate systems to achieve marginal improvement for years and are notoriously understaffed.
By giving them the right tools, so that they can do their jobs effectively and efficiently, should be priority number one.
5. You rely on institutionalized knowledge
Has a top member of your regulatory team left the organization, leaving you with no idea about what projects they had their hands in, the status of current submissions, broken down communications with external stakeholders, or lost critical tribal knowledge that wasn’t passed down?
Have you ever called that employee at their new company just to “pick-their-brain” because that critical information wasn’t transferred before they left?
Having a fail-safe in place now for when (not if) your top talent leaves prevents the loss of company and product specific tribal knowledge.
Bringing your regulatory processes into the digital age so your team and company can perform work within a central location ensures everything is properly documented and builds that critical archive of information. A unified system and collaboration hub keeps everyone on the same page within a single regulatory platform. Think of it as your company’s regulatory insurance policy.
Employees change roles, leave departments, and move on to other companies, leaving you to pick up the pieces. Retraining a new employee without the subject matter expert can cause delays and wasted time. So stop relying on disparate systems, disjointed processes, color-coded excel files, and emails that get lost in the shuffle and inhibit progress.
The good news
There is good news. Software solutions already exist that create a collaboration hub to help medical device companies actively navigate the changing regulatory landscape.
Software solutions such as Rimsys Regulatory Management Software can empower your current team. They provide better planning and tracking in a unified system that can monitor process metrics, milestones, and automatically inform submissions plan timelines with actual performance. A solution that connects planning to execution, allowing improved, real-time process monitoring provides teams visibility to quickly spot constraints and take action, allowing products to get through your regulatory process faster and with improved compliance.
It is time to set the new standard for the industry. It is time to go digital and start automating your broken systems.
