Let’s Talk Medtech

Decrypting FDA's Cybersecurity Policy


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Naomi Schwartz, the Senior Director for Cybersecurity Quality & Safety at Medcrypt, a medical device cybersecurity specialty firm, shares some interesting tidbits about FDA's upcoming Refuse-to-Accept (RTA) policy for Cyber Devices and Related Systems. The policy is effective Oct. 1 and Schwartz breaks down what the RTA will mean for medical device manufacturers and their FDA submissions.

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