Navigating Medical Device Cybersecurity Waters: Regulatory Similarities and Differences Between the EU and US

Although global medical device regulators have increasingly providedregulations and guidance on cybersecurity there are notable differencesin the way regulators include cybersecurity, and related safetyconcerns, in their overall regulatory framework. Yet, similarities existthat allow medical device manufacturers to optimize their cybersecurityefforts and address multiple global regulations at the same time. As anexample, this session will compare and contrast the different regulatoryconcepts and approaches taken by the European Union (under MDR / IVDR)and the US (under FDA). The speakers are recognized experts in theirrespective regions with a deep background in medical device regulationsand cybersecurity.