Day

June 20, 2014
FDA issued a draft guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This draft exercises FDA enforcement discretion to essentially deregulate MDDS and Imaging Storage and Coummincation systems despite their classifcation rules. The guidance is at the link provided and proposes the new policy and provides specific wording changes...
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http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/
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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.

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