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.
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
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
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
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
As organizations race to harness the power of artificial intelligence, many find themselves caught between ambitious expectations and operational realities. This session cuts through the noise to address the fundamental question: How do we move beyond the era of "impressive demos" to build AI systems that actually deliver sustainable business value in production?
Through concrete examples from clinical and medical applications within our organization, alongside insights from the broader medtech and pharma industry, we'll tackle the universal challenges facing any high-stakes, regulated environment. Whether you're in legal, regulatory affairs, R&D, or other mission-critical functions, the need for precision, auditability, and explainable outcomes remains constant, and so do the systemic barriers to achieving them.
This session introduces a systems thinking approach to AI adoption, moving beyond individual models to focus on the underlying infrastructure, data architecture, and organizational capabilities that make AI work reliably at enterprise scale. We'll examine what separates impressive demos from production-ready systems, and explore the notorious "valley of death" between innovation and implementation.
We'll dive into the reality behind the hype: why foundation models alone aren't enough, how data quality and governance become your competitive advantage, and why successful AI transformation requires both technical excellence and cultural evolution. The focus will be on building AI systems that are not only powerful but also transparent, auditable, and seamlessly integrated with business-critical workflows.
Designed for business leaders, technical teams, and end users across different business units and functions in the organization, this session provides a pragmatic blueprint for organizations serious about scaling AI, addressing the technical, operational, and strategic dimensions that turn AI promise into measurable business impact.
Key Takeaways:
- Why most AI initiatives fail to scale and how to avoid the "impressive demo" trap
- The infrastructure and data foundations required for production AI systems
- Building cross-functional teams and capabilities for sustainable AI adoption
- Practical approaches to bridging the gap between AI capabilities and business needs
- Understanding the shift from model-centric to system-centric thinking in AI implementation
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
- Working with challenging devices (case examples)
- Handling failing testing
- The importance of feasibility studies
- 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
- What are EU AI regulatory sandboxes and what are they used for?
- What information do we have on how these will be established in
member states?
implementation of AI Regulatory Sandboxes - How do these compare to the UK Airlock and the AI/GenAI approaches explored there?
- What opportunities do sandboxes provide and how can they help shape
the future of device and diagnostic development?
What do manufacturers and notified bodies need to be aware of? - Can you develop AI without the use of sandboxes?
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?
- What is cytotoxicity testing?
- Cytotoxicity testing – why does it fail so often?
- Points to consider when Cytotoxicity testing fails
- Case studies
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
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?
MDR vs MDCG definition for WET devices
Example of WET devices: perspective from notified body
Level of clinical evidence required for WET 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
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!
- Understand how medical claims are evaluated under MDR
- Identify common pitfalls in claim substantiation
- Explore strategies to avoid non-compliance and increase regulatory success
- Learn how to align CER with marketed claims
- AI in MedTech: legal and regulatory pathways
An overview of the legal landscape shaping AI and software in medical technologies, with a focus on key EU frameworks such as the AI Act, MDR/IVDR, and GDPR. The session will explore how evolving regulation is influencing innovation, market access, and clinical integration. - Cybersecurity and digital sovereignty
Key considerations for building legally compliant and trusted digital health infrastructure in Europe, including governance of sensitive health data, cross-border interoperability, and alignment with national digital strategies. - Delivering compliant innovation globally
A look at how legal, privacy, and ethical requirements are being embedded in the development and deployment of AI-driven healthcare solutions, and the practical implications for stakeholders across the digital health ecosystem with a global approach.
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
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?
- 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
- Understand how medical claims are evaluated under MDR
- Identify common pitfalls in claim substantiation
- Explore strategies to avoid non-compliance and increase regulatory success
- Learn how to align CER with marketed claims
As organizations race to harness the power of artificial intelligence, many find themselves caught between ambitious expectations and operational realities. This session cuts through the noise to address the fundamental question: How do we move beyond the era of "impressive demos" to build AI systems that actually deliver sustainable business value in production?
Through concrete examples from clinical and medical applications within our organization, alongside insights from the broader medtech and pharma industry, we'll tackle the universal challenges facing any high-stakes, regulated environment. Whether you're in legal, regulatory affairs, R&D, or other mission-critical functions, the need for precision, auditability, and explainable outcomes remains constant, and so do the systemic barriers to achieving them.
This session introduces a systems thinking approach to AI adoption, moving beyond individual models to focus on the underlying infrastructure, data architecture, and organizational capabilities that make AI work reliably at enterprise scale. We'll examine what separates impressive demos from production-ready systems, and explore the notorious "valley of death" between innovation and implementation.
We'll dive into the reality behind the hype: why foundation models alone aren't enough, how data quality and governance become your competitive advantage, and why successful AI transformation requires both technical excellence and cultural evolution. The focus will be on building AI systems that are not only powerful but also transparent, auditable, and seamlessly integrated with business-critical workflows.
Designed for business leaders, technical teams, and end users across different business units and functions in the organization, this session provides a pragmatic blueprint for organizations serious about scaling AI, addressing the technical, operational, and strategic dimensions that turn AI promise into measurable business impact.
Key Takeaways:
- Why most AI initiatives fail to scale and how to avoid the "impressive demo" trap
- The infrastructure and data foundations required for production AI systems
- Building cross-functional teams and capabilities for sustainable AI adoption
- Practical approaches to bridging the gap between AI capabilities and business needs
- Understanding the shift from model-centric to system-centric thinking in AI implementation
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
MDR vs MDCG definition for WET devices
Example of WET devices: perspective from notified body
Level of clinical evidence required for WET devices.
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?
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
- What is cytotoxicity testing?
- Cytotoxicity testing – why does it fail so often?
- Points to consider when Cytotoxicity testing fails
- Case studies
- Working with challenging devices (case examples)
- Handling failing testing
- The importance of feasibility studies
- 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
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?
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
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!
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
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
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
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
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
- AI in MedTech: legal and regulatory pathways
An overview of the legal landscape shaping AI and software in medical technologies, with a focus on key EU frameworks such as the AI Act, MDR/IVDR, and GDPR. The session will explore how evolving regulation is influencing innovation, market access, and clinical integration. - Cybersecurity and digital sovereignty
Key considerations for building legally compliant and trusted digital health infrastructure in Europe, including governance of sensitive health data, cross-border interoperability, and alignment with national digital strategies. - Delivering compliant innovation globally
A look at how legal, privacy, and ethical requirements are being embedded in the development and deployment of AI-driven healthcare solutions, and the practical implications for stakeholders across the digital health ecosystem with a global approach.
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
- What are EU AI regulatory sandboxes and what are they used for?
- What information do we have on how these will be established in
member states?
implementation of AI Regulatory Sandboxes - How do these compare to the UK Airlock and the AI/GenAI approaches explored there?
- What opportunities do sandboxes provide and how can they help shape
the future of device and diagnostic development?
What do manufacturers and notified bodies need to be aware of? - Can you develop AI without the use of sandboxes?
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.