Deep Dive: FDA Pre-Market Guidance for Medical Device Cybersecurity - Part 2 - ERP Spain.com - España y América Latina

In an effort to keep the industry ahead of cybersecurity vulnerabilities found in medical devices, The Food and Drug Administration (FDA) has updated a draft guidance document to help manufacturers incorporate cybersecurity best practices to address threats before devices go to market. In this educational webinar, Mike and Seth will discuss the updates made in this guidance and the reasons behind those changes. They will review some of the prescriptive best practices the guidance document endorses and discuss the impacts the FDA hopes this updated guidance will accomplish. Mike and Seth will also discuss the important and evolving role and responsibility of the FDA for the security of medical devices. In part 1, Mike and Seth discussed the background of the guidance document and dove into some of the anticipated changes that will be made in the new guidance. They also addressed General Principles of the guidance document and dove into risk assessments and threat modeling. In part 2, Mike and Seth will continue to dissect the guidance language and will cover the recommendations the document makes for designing trustworthy devices. They will review security best practices and match them to the recommendations made in the document. They will also discuss labeling and documentation recommendations. As in part 1, Mike and Seth will respond to questions from the audience throughout the discussion.