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.
- See how QPack helps you with with your medical device FMEA risk management
- Source: http://en.wikipedia.org/wiki/ISO_14971
ISO 9000 Quality Standards
- ISO 9001: Design and Manufacturing
- ISO 9002: Manufacturing Only
- ISO 9003: Inspection and Testing Only