FDA Presentation Intro to Regulated Software

The presentation “CDRH Regulated Software An Introduction” by John F. Murray Jr. CDRH Software Compliance Expert at FDA is a very good overview for those new to this topic. It covers device as well as production and quality system software, classification, and premarke review. The full presentation slides are at the link provided.

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
for more info!

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