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Implementing and Maintaining Changes to SaMD Under MDR

A session by Magdalena Kocot
Regulatory Project Manager, ICS

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About this session

The new EU Medical Device Regulation (MDR) will go into effect in a couple of months. It introduces a great number of changes and puts emphasis on the life-cycle approach to medical device management. These new regulations also influence fast-evolving SaMD products (Software as a Medical Device). Thus it is crucial to understand what are the regulatory implications for SaMD development and maintenance.

This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others. It will also provide guidelines on how to evaluate and implement changes throughout the lifecycle of software medical devices.

Presentation Takeaways - Understanding the new requirements for SaMD under MDR - Impact of the new regulations on the medical device software life cycle - Evaluating and implementing changes throughout the lifecycle of SaMD - Introducing changes into the medical device software certified under MDD

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