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

• 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

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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

• 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

• About FDA
  • Medical devices, IVDs, drugs, combination
  • products and CDx: FDA divisions and offices
  • FDA Centre for Devices and Radiological
  • Health (CDRH)
  • Code of Federal Regulations (CFR)
  • Standards and other guidance documents
• Harmony & Discord
  • A comparison of US and European Medical
  • Device Regulatory Affairs
  • Regulatory commonalities, overlaps and
  • discrepancies
  • Future trends
• An introduction to routes to the US Market
  • Classification
  • Premarket Notification – (510(k)
  • Introduction to Traditional, Abbreviated,
  • Special, de novo & Exemptions
  • Predicates & substantial equivalence
  • Premarket approval (PMA)
  • Modules, modular and full submissions
  • Role of QMS (CFR Part 820)
  • Quality Assurance
  • Quality Control

• Classification: routes to market
• Comparison with EU/UK
• The 513(g) procedure

• What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the
• manufacturer and FDA
• How to prepare a ‘pre-sub’ document
• The ‘pre-sub’ meeting
• FDA feedback & follow up with the Agency
• Next steps

• 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

• 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

• The 510(k) process, different types of 510(k) and De Novo submissions
• Predicate Devices
• Contents of a 510(k) submission
• Decision Summaries
• Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market

• The PMA process and different types of PMAs
• Contents of a PMA submission
• Summary of Safety and Effectiveness Data (SSED)
• PMA Annual Reporting
• Modifications to approved devices

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar  

• 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?

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar  

• 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

• Notification [510(k)] vs Approval (PMA) output data requirements
• Preclinical data: design verification
• Clinical data: design validation
• The importance of project management: saving time and cost to market
• Design change: pre-planned and/or response to market feedback

• Imposing Quality throughout the product lifecycle to save time and cost
• Role in Product Development, Design Control and Design Review
• Input to Risk Management
• Importance for manufacturing
• Quality Control
• Audits and Inspections
• Forthcoming regulatory changes

• 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!

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar  

• 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?

• Production and process controls
• Information Classification: General
• Inspection of measuring and test equipment
• Process validation