FDA Cyber Security Guidance Implementation
Zener Engineering Services Ltd • 29 June 2019
In October 2018 the FDA released a draft copy of ‘Content of Pre-Market Submissions for Management of Cyber Security in Medical Devices’.
Recently ZES supported a number of clients to achieve compliance inline with this draft guidance in anticipation of its approval, during the Medical Device 510(k) Clearance process and retrospectively.
It is anticipated that the new guidance will supersede current guidance issued by the FDA.
ZES provide expertise to help you and your medical device achieve compliance, by helping you with pragmatic implementation of the guidance.
Contact ZES with all your Medical Device Cyber Security concerns.
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