Earlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software (firmware) and includes the ever important postmarket management. Risk to device functionality or loss of important data due to a cybersecurity risk is a consideration that could result in bad outcomes for patients. Device manufacturers need to take a look at their own risk management programs and assure they have a comprehensive plan established.
Pearl Pathways looks forward to the opportunity to work with you and provide support to your ongoing successful product development activities including risk management program development as part of your overall Quality System. Contact us to set up a discussion.