Insights and Highlights from RAPS Convergence 2025 in Pittsburgh

Two weeks ago, the Qserve team joined regulatory professionals from around the world at the RAPS Convergence 2025 in Pittsburgh, one of the most anticipated gatherings in the regulatory community. From thought-provoking sessions to engaging conversations at the exhibit hall, the event proved once again why it is the go-to place for sharing knowledge, building connections, and shaping the future of MedTech regulation. 

A Time of Change in the EU Regulatory Landscape

For Gert Bos, the conference offered both professional and personal highlights:

“RAPS Convergence 2025 in Pittsburgh was a great event, with high-quality lectures and some good discussions in the exhibit hall”, Gert shared. “The plenary panels and in-depth sessions on developments in the EU were particularly insightful, as the unimaginable seems to be happening: a targeted revision of the EU MDR and IVDR while implementation is still ongoing.” 

He emphasized that the key question remains whether stakeholders will use this revision to accelerate implementation or whether it will lead to more delays. “Either way,” Gert added, “we’ll be ready to support.” 

The week was also memorable for Gert personally, as he was honored with the RAPS Founders Award. “It was wonderful to receive so many congratulations and supportive words from colleagues,” he said. “That made this event even more special.” 

EU MDR Kick-Off and Notified Body Insights 

One of the most discussed sessions was the EU MDR Kick-Off, featuring representatives from notified bodies, industry, law, and consulting. The talks highlighted the urgent need for both rapid improvements and structural enhancements in the regulatory system, leading toward a two-tier change by December 2025. 

Gert, representing Qserve, discussed the behavioral shifts needed to drive true progress. “The key changes we need are behavioral rather than legislative,” he noted, emphasizing the importance of structured dialogues, reducing data expectations for orphan devices, and improving the reliability of the system for SMEs. 

Later, during the EU Notified Body Forum, Gert joined Bassil Akra and others to share best practices from industry and notified bodies. “We need to get the train rolling faster,” Gert urged, calling for early and continuous dialogue to prevent new bottlenecks in the system. 

Structured Dialogue: 10 Topics to Engage With Your Notified Body 

Communication was also a major theme in the session “Structured Dialogue: 10 Effective Topics to Engage With Your Notified Body,” co-led by Gert Bos and Suzie Halliday. With insights from BSI, TÜV SÜD, Bianca Lutters (Qserve), and Leo Hovestad (Elekta), the discussion became one of the most interactive of the conference. “The audience stayed long after the session ended,” Gert noted, “which shows how valuable open dialogue is in our field.” 

Spotlight on Qserve Learn and Qserve Insight 

Celien van Lochem and Amé Huige highlighted another type of dialogue — one focused on learning and innovation: “One of our personal highlights was the interest shown in our new platforms, Qserve Learn and Qserve Insight,” Celien shared. “It was great to see how well they were received and how they sparked meaningful conversations about training and knowledge-sharing,” Amé added. 

Modeling the Future: In Silico Tools and Orphan Devices 

For Bianca Lutters, the conference offered a deep dive into emerging technologies. “The session ‘Modeling the future: regulatory perspectives on in silico tools for medical devices’ provided a great overview of how in silico tools can replace or supplement preclinical studies,” she explained. “Notified bodies confirmed that these tools are acceptable when properly justified.” 

Bianca also reflected on the discussion around orphan devices, where regulators showed openness to flexibility. “They understand the challenges manufacturers face and are willing to CE-mark orphan devices with limited clinical data,” she said. “However, the financial challenges remain, as there are still no incentives for companies bringing these much-needed devices to market.” 

Keeping the Patient in Focus 

Mindy McCann captured one of the conference’s most resonant messages: “Right and fast can coexist peacefully.” She added, “The focus on the patient was reflected in almost every session. It was a great reminder that while we focus on compliance, we must never lose sight of the bigger picture — patient care.” 

Mindy also found the RAPS BOD Roundtable on Ethical Challenges in Regulatory particularly meaningful. “It’s easy to talk about ethics until your job is on the line,” she said. “This session opened an honest conversation about a topic that touches all of us.” 

Productive Conversations and Great Connections 

For Jeff Habecker, the conference was not only informative but also highly productive. “We had great conversations with companies from across the MedTech landscape and saw genuine interest in our full range of services,” shared one of our colleagues. “It was encouraging to see how our expertise and solutions resonate with the challenges and ambitions of today’s manufacturers.” 

The atmosphere at the booth was energetic throughout the event, with visitors eager to exchange insights and explore future collaborations. “And by the way, our booth looked great”, He added with a smile.

Looking Ahead 

As the Qserve team reflected on a successful RAPS Convergence 2025, Gert shared his enthusiasm for the months ahead: “We’re looking forward to the upcoming RAPS workshop in Rotterdam, the RAPS/TOPRA conference in London, and RAPS EU Convergence 2026 in Lisbon,” he said. “We hope to meet and engage again with many of you there.” 

If you want to continue the conversation, explore our services, or learn more about Qserve Learn and Qserve Insight, contact us today. We’d love to discuss how we can support your regulatory and training needs.