ISO 14971
What is ISO 14971?
As the only internationally recognised standard for risk management for medical devices, ISO 14971 has become a fundamental component for satisfying regulatory requirements in most major markets.
The purpose of ISO 14971 is to aid medical device manufacturers in implementing, cataloguing and maintaining a Risk Management Process to:
- Determine hazards and potentially hazardous conditions.
- Estimate and interpret the associated risk.
- Control those risks.
- Continually monitor the effectiveness of the controls put in place throughout the product's life cycle.
