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.

  • Design Engineers
  • Software Engineers
  • Software Validation Specialists
  • Risk Managers
  • Complaint Managers
  • Complaint Analysts
  • Regulatory Affairs Managers
  • Submission Specialists

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence via a systems approach to operations management. Mr. O’Leary boasts more than 30 years’ experience in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.