ISO 14971 For Medical Device Risk Management

ISO 14971 represents the requirements for a medical device risk management system.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485.

ISO 9000 Quality Standards

  • ISO 9001:  Design and Manufacturing
  • ISO 9002:   Manufacturing Only
  • ISO 9003:  Inspection and Testing Only