top of page

In an uncharacteristically quick move, the FDA released this official guidance less than a year after the draft was released for comments. This guidance for medical device manufacturers "recognizes today’s reality – cybersecurity threats are real, ever-present,  and continuously changing."

For more information on the FDA Postmarket Cybersecurity Guidance, see the below post from Dr. Suzanne B. Schwartz

http://blogs.fda.gov/fdavoice/index.php/2016/12/managing-medical-device-cybersecurity-in-the-postmarket-at-the-crossroads-of-cyber-safety-and-advancing-technology/

Recent Posts

See All

Let's take a moment to get back to the basics of cybersecurity in medical product design. The goal is to prepare a solid list of things to be on the lookout for when doing a cybsecurity risk analysis.

Click here for more information The Medical Device Security 101 Conference, hosted by the University of Michigan’s Archimedes Center for Medical Device Security, is a 2-day educational workshop taking

bottom of page