Day

September 26, 2019
The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
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