Ten years ago, the FDA’s Premarket Cybersecurity guidance was nine pages; today, the latest premarket guidance is 57 pages long and covers premarket cybersecurity activities and includes activities to be performed during the post-market life of your device.
Are you ready? Some of these new activities need to be in place from the start of a new medical device project; others affect how cybersecurity-sustaining activities are performed. Maybe you’re just preparing for your clinical trials. Do you know what is optional for cybersecurity during your trials required for your production version of the new device?
Don’t wait too long into the development process, as many of these new cybersecurity activities will be costly and impactful to your new design if performed late in development.
If you have heard that the FDA is now enforcing new cybersecurity requirements but have put it off because of all the other mandates of creating a new medical device, then this presentation is for you. Garrett Schumacher, Technical Director of Cybersecurity at Velentium, will address this critical topic Wednesday, February 7 at 10:15 am.