Congressional hearing on SW as a Device

The link provided is to an article on summarizing the congressional hearing last week on whether software should be regulated by FDA as a medical device. This is related to the Blackburn Bill which would exempt many standalone software medical applications, if passed into law, from FDA regulation.

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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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