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Overview
Software medical devices rarely stay static after release. Updates to functionality, cybersecurity measures, integrations, AI models, usability, and performance all introduce questions around validation, documentation, risk management, and regulatory impact.

As development cycles become faster and software ecosystems become more connected, managing change in a compliant and controlled way is becoming increasingly important for manufacturers and regulatory teams alike.

This European SaMD Meetup session will focus on the practical side of SaMD Change Management, including how organisations assess software changes, maintain documentation alignment, handle post-market considerations, and navigate evolving regulatory expectations across MDR, IVDR, and related frameworks.

The discussion is intended for professionals working across regulatory affairs, quality, software development, cybersecurity, and digital health.

Agenda:

Introduction (5–10 minutes) - Host (Ivo Flipse)

  • Welcome and overview of change management considerations for SaMD.
  • Why software changes create unique regulatory and operational challenges.

Session 1 (10 - 15 minutes + Q&A) - Scarlet (Steven Byrne)

  • Software lifecycle changes and regulatory impact assessment.
  • Managing updates across validation, risk management, and technical documentation.

Session 2 (10 - 15 minutes + Q&A) - MedQAIR (Monique Greijmans)

  • Operational challenges around software updates, integrations, and post-market changes.
  • Maintaining alignment between development, quality, and regulatory teams.

Session 3 (10 - 15 minutes + Q&A) - Industry Speaker (TBC)

  • AI/ML systems and evolving change management considerations.
  • Governance, oversight, and maintaining compliant software over time.

Conclusion (5 minutes)

  • Wrap-up, discussion, and key takeaways.

Event Date & Time

  • May 21st — 7:30 PM – 9:30 PM CET

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