FDA Final Postmarket Surveillance Guidance

The US FDA issued a final guidance entitled: “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” dated May 16, 2016. The full guidance is at the link provided. .This includes special provisions for devices used on pediatric populations.

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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