IMDRF Safety/Performance of Medical Devices/IVDs

The International Medical Device Forum, which FDA participates in, released a draft for comment entitled, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.  This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles of Safety and Performance” that, when met, indicate a medical device is safe and performs as intended.

IMDRF Safety and Performance

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

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