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PreMarket Guidance
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Classroom Contents
Safety Implications of Medical Device Cybersecurity
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- 1 Introduction
- 2 Medical Device Cybersecurity
- 3 Shared Responsibility
- 4 FDAs Response
- 5 PreMarket Guidance
- 6 PostMarket Guidance
- 7 Cybersecurity Risk Assessment
- 8 FDAs Thinking
- 9 Safety Action Plan
- 10 FDA Public Workshop
- 11 Stakeholder Study
- 12 CMS in Healthcare
- 13 Wannacry
- 14 Medical Device Sandbox
- 15 Analysis Boards
- 16 Stakeholder Feedback
- 17 We Heart Hackers Challenge
- 18 FDA
- 19 Key takeaways
- 20 Application
- 21 FDA Contacts
- 22 Recertification
- 23 Remote support
