Day Four – 19 June 2025Thursday, 19 June 2025

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.

• Introduction to ISO 14971 and its Importance in Software as a Medical Device (SaMD)
• Key Principles and Concepts of the Standard for SaMD
• Overview of the Risk Management Process in SaMD
• Application of ISO 14971 in the Development and Maintenance of SaMD
• Common Pitfalls and Best Practices in SaMD Risk Management

• Comparison of cybersecurity legislation from both Europe and the US

  • How do they compare?

  • Are there places in which one can learn from the other?

  • How can manufacturers adhere to both sets of regulations, if operating in both regions?

• Tips for best practices

  • Risk and mitigation techniques for cybersecurity

  • Dealing with breaches

• Manufacturer obligations for medical AI systems

• MDR and AI Act requirements regarding explainability and transparency

• Operator obligations for medical AI systems

  • German and European operator law

• Implementation of obligations in inactive processes of manufacturers and operators

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.

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.

• What are the newest pieces of legislation which have been released relating to software and AI/ML in Europe?

  • What have the biggest impact on industry?

• What's in the pipeline?

  • Regulatory priorities for the next year

• UK’s position on AI innovation
  • How the UK’s approach to AI devices is shaping up
  • The role of international reliance in deploying AI globally
• EU’s position on AI innovation
  • The impact of the EU AI Act on new devices
• A global look ahead
  • Emerging regulatory trends in AI regulation and their ramifications

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!

• What is classified under Annex 16?

  • What is the latest update to the common specifications?

  • Are there proposed changes which will affect manufacturers?

• Collecting clinical evidence

  • When and how to collect clinical data under Annex 16

  • How to demonstrate benefit risk

• Biocompatibility beyond check boxes:

• How to source and analyze post-market data for Biological Evaluations

• Steps to integrate this data and the role of Risk Management

• Discussing real-world examples to demonstrate the process

• Identifying the intersection of toxicology and biocompatibility

  • When does 1 feed into the other?

• Best practices for identifying the needs of your device

  • When does a device need a toxicological risk assessment?

  • Are there any exceptions?

• Latest regulatory updates from the US

• How different are they from European updates?

• Are there places of alignment between the 2 regions?

• Where can manufacturers streamline documentation or workload?

• The future

  • US priorities for software and AI/ML in the coming year

• Understand Risk Management in a Simplified and Exercisable Way
• Practical Implications of ISO 14971
• Health Hazard Analysis Why, When and How
• Pitfalls and Lessons Learned shared for the benefit of our Patients

• Working with challenging devices (case examples)
• Handling failing testing
• The importance of feasibility studies

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.

• With the rise in AI, how are companies applying this to ease biocompatibility workload and analysis?

  • Can generative-AI be used in documentation completion and submission?

• Are notified bodies and regulators accepting of AI use?

  • How is this being regulated?

  • Can we expect further guidance on using AI for biocompatibility?

• Locking down risk management strategies

  • Which regulations and guidance reference risk management for AI?

  • When to start thinking about and implementing risk management

  • How do you apply risk management principles for AI-enabled devices?

• Case study: risk management in action

• In this opening half an hour, take the time to reflect on your current software and AI journey and discuss with colleagues

• Use the post-it notes provided to write down your top comment, question or concern

• These will then be addressed by our expert panel during tomorrow’s final session

• What is cytotoxicity testing?
• Cytotoxicity testing – why does it fail so often?
• Points to consider when Cytotoxicity testing fails
• Case studies

• What are regulatory sandboxes and what are they used for?

  • What information do we have on how these will be established in member states?

• What do manufacturers need to be aware of?

  • Can you develop AI without the use of sandboxes?

• What opportunities do sandboxes provide and how can they help shape the future of device and diagnostic development?

• Toxicological risk assessment of chemical constituents of medical devices: application of ISO 10993-17

• Hazard identification and implementation of toxicological screening limit

• Biological risk estimation within the risk management framework

• 1 year on from the MDCG guidance on Orphan devices, what are the current experiences in regulating them?

• Is the guidance clear or is further guidance needed?

• How many have been certified so far?

• How does the future look for Orphan devices?

• Review of published literature on the mechanism of Electropolishing
• Review of extractables data from ZB devices to show that Electropolishing can effectively reduce/remove mfg materials used prior
• Application of Electropolishing on future risk assessments
• Similar manufacturing steps (such as anodization and passivation) that provide similar advantages in risk assessments performed per ISO 10993

• MDR vs MDCG definition for WET devices

• Example of WET devices: perspective from notified body

• Level of clinical evidence required for WET devices.

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any left over burning questions!

Please contact: Kristen Schott – kristen.schott@informa.com if you are interested in participating as a speaker, panellist, moderator or hosting a webinar  

• With the documentation for clinical and performance evidence ever increasing, can companies use AI to help with workload?

• Use of generative-AI in documentation completion or answer generation

• Working example

  • Successful uses of AI

  • Risks to be considered

    • Patient safety

• With EMA’s Darwin Project now in full operation, what are the implications for medical device and in vitro diagnostic manufacturers?

  • Intersection with the European Health Data Space (EHDS)

• Which lessons can be implemented cross-industry

  • Implementation of platforms for data and real world management