Definition
ISO 14971 is an international standard specifying a process for managing risks associated with medical devices throughout their lifecycle.
Human Explanation
It provides a structured way to identify hazards, evaluate associated risks, apply controls and monitor their effectiveness.
Why it Matters
Systematic Risk Management supports patient and user safety and informed lifecycle decisions.
Conceptual Boundary
ISO 14971 does not eliminate risk or define a universal acceptable level. It specifies a process for managing risk.
Practical Perspective
Risk Management should remain connected with design, Validation and production and post-production information.
Related Concepts
Official Source
ISO 14971:2019 — Medical devices — Application of risk management