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February 1, 2021
Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...
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Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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