ISO 14971: Application of Risk Management to Medical Devices
January 1, 20261 min read
Regulatory Guidance
This content is provided for educational purposes. Always consult official regulatory sources and qualified professionals for compliance decisions.
Defines the process for identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle.
Overview
This standard identifies the requirements for compliance within the global healthcare ecosystem. Adherence ensures patient safety and regulatory alignment.