Day Four – 19 June 2025Thursday, 19 June 2025 - CEST Time Zone

The U.S. workshop at the Medtech Summit 2025, chaired by Holger Wagner and Steven Weber, dives into regulatory challenges in medical technology with an interactive twist. Through lively sessions, talks, and roundtable chats, it’ll break down U.S. FDA updates for newcomers and pros alike, showing their worldwide ripple effects and handing participants tools for regulatory wins.

After an overview of FDA basics, the workshop tackles the keypoints of 510(k) and DeNovo processes.

The prominent Breakthrough Program will be discussed in a special topic in detail, to show the expedited process that accelerates the market approval of innovative medical devices with high patient benefits, such as life-saving technologies. It offers manufacturers priority review, flexible clinical data requirements, and close collaboration with the FDA to shorten development times.

Differences in complaint management between US and global standards will be examined, with a focus on post-market surveillance. Handling complaints right keeps patients safe and regulators happy, though the bar for reporting and follow-up differs a lot across borders.

Another hot topic is the switch from Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) kicking off in Feb. 2026, syncing FDA rules with ISO 13485:2016. It’s a simpler setup for quality management, but companies will need to hustle to tweak processes and stay compliant. Attendees will walk away with a clear take on cracking the U.S. market. MDR (EU) audits versus FDA inspections get a look too, digging into their scope, timing, and grit—must-know stuff for juggling both.

The latest FDA news rounds up policy shifts, updates, and enforcement vibes, offering real takeaways. Participants will see how these shake up submissions and inspection prep.

Looking ahead, “FDA – What’s Next?” and “Prepare for 2026” tackle buzz like AI in devices and cybersecurity risks. These chats sketch out what’s coming and spark planning through open discussion. The day wraps with a Q&A, letting RA pros, quality folks, and innovators dig into practical tips.

As a highlight the prominent Breakthrough Device Designation will be discussed in a special topic in detail, to show the expedited process that accelerates the market approval of innovative medical devices with high patient benefits, such as life-saving technologies. It offers manufacturers priority review, flexible clinical data requirements, and close collaboration with the FDA to shorten development times.

Differences in complaint management between US and global standards will be examined, with a focus on post-market surveillance. Handling complaints right keeps patients safe and regulators happy, though the bar for reporting and follow-up differs a lot across borders.

Another hot topic is the switch from Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) kicking off in Feb. 2026, syncing FDA rules with ISO 13485:2016. It’s a simpler setup for quality management, but companies will need to hustle to tweak processes and stay compliant. Attendees will walk away with a clear take on cracking the U.S. market. MDR (EU) audits versus FDA inspections get a look too, digging into their scope, timing, and grit—must-know stuff for juggling both.

The latest FDA news rounds up policy shifts, updates, and enforcement vibes, offering real takeaways. Participants will see how these shake up submissions and inspection prep.

Looking ahead, “FDA – What’s Next?” and “Prepare for 2026” tackle buzz like AI in devices and cybersecurity risks. These chats sketch out what’s coming and spark planning through open discussion. The day wraps with a Q&A, letting RA pros, quality folks, and innovators dig into practical tips.