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September 18, 2014
The IMDRF issued “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” This guidance provides terminology and possible framework for the industry and regulators to work from in discussing and dealing with risk related to standalone software used as a medical device.
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Cybersecurity Review

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

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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+1-781-721-2921
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