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QMSR is coming. Is your quality system ready?

This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

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Move Fast and Stay Compliant: Rethinking Change Control for Software Medical Devices in Europe

Software moves at a fundamentally different pace than the hardware in a medical device. A change that takes a software team an afternoon to build and ship can take a Notified Body months to review. What constitutes a substantial change under Regulation (EU) 2017/745 (EU MDR) varies among stakeholders, and guidance is opaque. For manufacturers building AI-enabled, adaptive, or rapidly iterating software medical devices, the gap between development velocity and regulatory cadence has become one of the defining challenges of bringing a product to market and maintaining it in Europe.

This session unpacks what the EU MDR actually requires for the change management of Software as a Medical Device, where the friction points lie, and what good looks like in practice. We'll work through the substantial change framework requiring pre-approval, examine why SaMD breaks the traditional change-control model, and explore practical strategies, from change classification discipline to release batching, that high-performing teams use to ship faster without losing compliance. Finally, we'll look ahead to the potential of Predetermined Change Control Plans (PCCPs): how the FDA framework works today, what the EU is signalling through the AI Act, and how manufacturers can start preparing now for a PCCP-enabled future in Europe.
 

What you'll learn:

  • The EU MDR change-management framework
  • Why SaMD breaks traditional change control
  • Solutions for faster, more efficient change management
  • The future: Predetermined Change Control Plans

Watch now!
Move Fast and Stay Compliant Rethinking Change Control for Software Medical Devices in Europe
Who should attend?
  • Quality and regulatory affairs professionals at SaMD companies
  • Product and engineering leaders preparing for submission
  • Founders and executives at pre- and early post-market SaMD companies
  • Anyone using AI in their technical documentation or compliance preparation
Register Now  

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