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