Thank you for joining us at RAPS Convergence in Long Beach, California

RAPS Convergence was an excellent opportunity to connect and learn more about the latest developments within the industry. During the event, attendees and exhibitors had the chance to visit us at booth 725, where they engaged with our team of knowledgeable consultants specializing in IVD, MD, clinical, and global registrations. It was an enriching experience as they could ask questions, gain valuable insights, and discover how Qserve could effectively support their regulatory needs.  

Raps Convergence began on the opening night with a Career Development Session for Students where Keith Morel, VP of Regulatory Compliance and Principal Consultant, shared his journey into Regulatory Affairs (RA). Keith Morel: 'This session attracted around 30-40 students and featured speakers, including myself, sharing our journeys into RA. I highlighted the significance of RA and explained that those starting in the industry face several key decisions:

• Product Focus: Choosing between devices, drugs, IVDs, cosmetics, food, or combination products.
• Role/Function: Deciding whether to pursue RA, QA, CA, R&D, or Marketing.
• Organization Type: Selecting whether to work for a manufacturer, regulator, Notified Body, contract design/manufacturing house, or as a consultant.

I outlined the pros and cons of each path, such as depth at a manufacturer versus breadth at a Notified Body or consultant, and offered strategies for gaining experience, including internships, job-hopping, mentorships, and rotational programs like Abbott's Regulatory Affairs Development (RAD) Program.'

Gert Bos, Executive Director and Leading MDR Expert at Qserve hosted the official opening ceremony together with Bill McMoil (RAPS Executive Director).

During the first official day of RAPS, Gert Bos joined the session 'Future State of Europe' as a speaker. This panel focused on the question if the current EU regulations are fit for purpose. Huge delays, concerns for products leaving the market in large volume, no attention to special patient groups, orphan devices, SME’s, innovation. The lobbying for better legislation, and for addressing some of these issues has meanwhile started, whereas the formal review of the system has been initiated, moving into data collection and open feedback consultation in the next few months. Gert Bos: 'Let’s try and make it simpler by learning from experiences and past mistakes.'

Pictured above: Gert Bos during the 'Future State of Europe' session.

Sue Spencer, Head of IVD, moderated the session ‘UKCA & Market Developments’. This session provided an in-depth explanation of the current UKMDR 2002 for medical devices and IVDs, including PMS requirements, and introduced the proposed Core and Enhanced UKMDR with details on implementation timelines and transitions. A panel discussion featuring perspectives from industry, UK Approved Bodies, the UK Competent Authority, and UK Reps concluded with a Q&A, offering attendees a comprehensive understanding of the regulatory landscape and its upcoming changes. Sue Spencer moderated the session.

Picutred above: Sue Spencer during the ‘UKCA & Market Developments’ session.

Gert Bos joined the 'Notified Body Forum: State of Play EU MDR and EU IVDR' as a speaker. Gert Bos: 'This forum discussed the current state of the notified body landscape and the status of device manufacturers in their compliance processes. I presented observations on manufacturer  behaviour, which can be categorized into three groups. The first group consists of early adopters who now face significant challenges in keeping their MDR devices on the market due to lengthy change review processes and more rigorous expectations during renewal reviews. The second group is actively progressing with their submissions and diligently working towards completion. The third and largest group has either placed their MDR applications on hold or is just beginning the process. A key issue is that notified bodies are struggling to staff their technical teams for reviews and audits. If the available resources are not effectively utilized, we face a new bottleneck when many manufacturers submit their files and audits at the last minute. The time to act is now!’

Picutred above: Gert Bos during the ‘Notified Body Forum: State of Play EU MDR and EU IVDR’ session.

Robert Paassen, Startup Lead at Qserve joined the session ‘Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs', dedicated to medical device startups. Robert Paassen: 'During my interactive session with Matthias Fink (Team Akra) and Rene Pot (IndigoMed), we discussed key points relevant to startups. I focused on lessons learned from working with startups, highlighting common pitfalls and strategies to avoid them. The presentation resonated well with the attendees, sparking a productive discussion. A key takeaway from the session was that many startups are currently focusing on the US market due to the evolving and unpredictable regulatory environment in Europe. We emphasized the importance of thorough planning from the outset, including a well-defined regulatory and clinical strategy, as well as detailed documentation of the design and development process to ensure compliance with regulations.'

Picutred above: Robert Paassen during the ‘Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs’ session.

Sue Spencer joined the session ‘Structured Dialogue for (IVD) Medical Devices in Europe’, featuring a panel discussion on the structured dialogue process between manufacturers and notified bodies, as outlined in MDCG 2022-14, emphasizing its role in improving the efficiency and predictability of the conformity assessment process while maintaining the impartiality of notified bodies. Panelists shared practical experiences, both positive and negative, and explored how structured dialogue can streamline regulatory compliance, with a focus on its boundaries and potential industry positions.

Picutred above: Sue Spencer during the ‘Structured Dialogue for (IVD) Medical Devices in Europe’ session.

As one of the final sessions for the RAPS Convergence, Gert Bos joined the ‘Updates in Pediatric Medical Device Development project SHIP-MD: New FNIH leadership vision’ as a speaker. This panel compared the US regs and guidance with the EU situation. Whilst the US has a special program in place for pedriatrics, EU is not in that state, and devices for this special patient group are under pressure as in (clinical) validation there might not be sufficient date for this subgroup of patients. The good news is that this gap in EU is being recognised by various stakeholders, gearing up to the evaluation of the MDR 10 year after publication. Until we provide more legal clarity, current rules apply, and with guidance and emphasis on orphan devices and innovation, a more streamlined process with sufficient structured dialogues between manufacturer and notified body continue to be the basis of the conformity route. The session concluded that sharing and combining clinical and performance data from all over the world will be essential. And in time these niche products could have a great potential to be reviewed in a more concerted global approach.

New Services: Qserve Learn and Qserve InSight

At the 2024 RAPS Convergence, Qserve launched Qserve InSight, an innovative regulatory intelligence platform designed to help companies stay ahead of rapidly changing regulations. This new service simplifies compliance by offering real-time updates, expert summaries, and impact assessments, all through an intuitive dashboard. Qserve InSight is available in three packages – Basic, Informed, and Strategic – tailored to meet diverse regulatory needs. By centralizing global regulatory updates and providing actionable insights, Qserve InSight helps companies prioritize compliance and avoid potential non-compliance risks. 

In addition, Qserve introduced Qserve Learn, an innovative e-learning platform tailored for regulatory, quality, and clinical professionals in the medical device and in-vitro diagnostics (IVD) industries. Offering flexible, on-demand learning, Qserve Learn allows users to advance their skills at their own pace from anywhere. The platform features interactive modules, personalized learning paths, and industry-recognized certifications, ensuring professionals stay ahead in the fast-evolving MedTech landscape. With Qserve Learn, you can access cutting-edge insights, simulations, and case studies, transforming professional development into an engaging and dynamic experience.

Thank you for joining us

Overall, the Convergence atmosphere was filled with enthusiasm as professionals from various corners of the regulatory affairs field came together to share experiences and knowledge. It was truly a memorable occasion that allowed us to connect with like-minded individuals and strengthen our commitment to regulatory excellence.  

We appreciate everyone who stopped by our booth and engaged with us. Your interest and participation made RAPS Convergence a resounding success. We look forward to the opportunity to continue supporting you in your regulatory endeavors in the future. 

Looking forward to seeing you in Brussels from May 13-16 for Euro Convergence, and later in Pittsburgh for RAPS Convergence from October 7-9!