How Are You Managing Your Postmarket Cybersecurity Vulnerabilities For Medical Devices?

By Deb Bartel, 5th January 2017

At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices to inform industry of recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits for their medical devices. What is in the FDA Guidance Document: This  … Read more

Are You Following the FDA Medical Device Cybersecurity Guidance?

By Deb Bartel, 18th February 2016

In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety. What’s new in this draft FDA guidance document: Manufacturer’s Responsibilities This guidance emphasizes that medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities.  This draft FDA document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These  … Read more