Description: Cybersecurity has gained increased focus across many global regulatory jurisdictions, including the United States (US), European Union (EU), Australia, Canada, Asia, and others. In the past year, the regulatory expectations have moved from foundational expectations to true technical rigor and specificity. This lecture will review not only the written expectations of key jurisdictions but also the "unwritten" expectations. The goalpost for what sufficient regulatory documentation is needed to meet regulatory expectations has shifted and this session will review the most critical areas to focus on to meet cybersecurity expectations, including security risk management, threat modeling, security-specific labeling, and postmarket security plans. The primary focus will be on the EU and US, specifying what an acceptable documentation package looks like for cybersecurity.
Learning Objectives:
Upon completion, participant will be able to understand which US Premarket Cybersecurity draft guidance expectations are aligned with existing QSR expectations and therefore expected in a US submission.
Upon completion, participant will understand which cybersecurity documentation is necessary for alignment with MDR expectations, focusing on MDCG 2019-16 and where we have seen pushback on certain documents
Upon completion, participant will be able to understand which types of documents are a major focus and how to ensure that your next submission is ready for review.
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