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