Congressional hearing on SW as a Device

The link provided is to an article on mobihealthnews.com 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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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Regulatory submission pre-review
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  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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