The speaker will discuss some of the challenges around Medical Device Software compliance with MDR. The attendees will have the opportunity to learn more about how BSI evaluates Medical Device Software. There will be a focus on key requirements, guidance documents and standards. The speaker will also focus on software driving or influencing the use of a medical device and key requirements. The speaker will share the lessons learned from the past MDSW assessments under MDR and the common gaps identified.
Sreenath Sukumaran, BSI Group
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