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Home » Store » Webinar Recordings » Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

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Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

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Cybersecurity and Risk Management for Medical Devices: Pre-market to Post-market Process Planning

If your medical devices incorporate software, they may be targets for cyber-crooks. It’s time you adopted a strategy to gain information, evaluate it, and take action — including regulatory responsibilities. This FDAnews presentation provides the regulatory information you need to stay compliant.

Background: The CDRH has issued two Guidances relating to cybersecurity. The pre-market guidance came out in 2014 but devicemakers still are absorbing its provisions. The post-market guidance was issued just seven months ago. Both treat cybersecurity as an element of risk management and utilize the process, with some modification, of ISO 14971:2007.

Device guru Dan O’Leary has analyzed both guidances and fashioned a suite of four spreadsheets that make compliance easy. Participants in this learning session receive all four spreadsheets, plus a glossary, as FREE bonuses. Here’s a preview of what Mr. O’Leary will cover:

  • A design control framework for cybersecurity
  • The role of software verification and validation in cybersecurity
  • Identifying expected cybersecurity documents in the Design History File
  • “Level of Concern” — what it is, how to determine it, how it shapes your submission documentation
  • Post-market information, sources, and effect on cybersecurity
  • Controlled risk vs. uncontrolled risk: How to determine each, how each affects subsequent regulatory actions
  • The CDRH and you: When a change to a marketed device (including cybersecurity fixes) is a reportable event
  • And much more!

Five FREE Bonuses

  • Spreadsheet to determine if an article is an accessory
  • Spreadsheet to determine Level of Concern for a Software Device, plus documentation to include in a submission
  • Spreadsheet to help assess exploitability of a cybersecurity vulnerability
  • Spreadsheet to determine when a correction or removable is reportable. (Includes tab related to cybersecurity)
  • Glossary of terms

Cyber-calamity is an area where the FDA wants to help protect you. Learn what the agency expects in return.

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