MEDICAL DEVICE QUALITY IMPROVEMENT: IMPLEMENTING POSTMARKET CYBERSECURITY PROGRAMS ALIGNED WITH NEW FDA GUIDELINES

The FDA has published final Postmarket Cybersecurity guidance for connected medical devices, which is the agency’s latest guidance to compliment the 2014 document on pre-market cybersecurity management and FDA notifications. Device manufacturers are now advised to produce and implement a structured and comprehensive program to manage cybersecurity risks throughout the product lifecycle, while continually addressing vulnerabilities before they can be exploited and cause harm. With the ever-shifting risks associated with connected device cybersecurity on the rise, manufacturers must prioritize managing risks and combating cyber threats. This program will include a discussion of the following:

• Overview of the new FDA guidelines and background on FDA’s device regulation
• Practical planning and budgeting for effective program management
• Methods for continuous cybersecurity monitoring and communication
• Incorporating core NIST principles and coordinated vulnerability disclosures

Speakers:
Cori Annapolen Goldberg
Partner
Norton Rose Fulbright US LLP

Kimberly J. Gold
Sr. Associate
Norton Rose Fulbright US LLP

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​