Call us now:
An important and comprehensive read from the US Food and Drug Administration. That has issued final guidance for the management of cybersecurity in medical devices. Setting out the foundational requirements and processes for medical device manufacturers to manage cybersecurity risks of their devices across their life cycle.
The scope is far reaching, affecting devices ‘with cybersecurity considerations, including but not limited to devices that include a device software or that contain software (including firmware) or programmable logic. That are
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals.
The guidance sets out requirements for companies that manufacture and support medical devices, demonstrate the management of cybersecurity risk through a secure product development framework (SPDF), and over the data they collect or manage from those devices.
@Thaddeus Dziekanowski Brian D. McCarthy Faisal Khan
Veritas GRC FDA
#cybersecurity #cyberriskmanagement #cyberattack
View Original Post
https://www.linkedin.com/feed/update/urn%3Ali%3AugcPost%3A7345751208764010496