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October 24, 2020
The FDA recently announced the addition of 25 new tools to the Catalog of Regulatory Science Tools to help assess medical devices. CDRH catalogues regulatory science tools on this webpage to help improve the development and assessment of emerging medical technologies. Of the 25 tools added, some items of interest are: Laboratory Accuracy Evaluation of...
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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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