What is the difference between ISO 14971 and ISO 13485?

ISO 14971 and ISO 13485 are two distinct but complementary international standards used in the medical device industry. ISO 13485 requires organizations to establish a risk management process as part of their quality management system, and ISO 14971 provides the detailed guidance on how to implement this process effectively.

The latest version, ISO 14971:2019, updates the standard with a new chapter structure, clarified technical requirements, and a focus on the benefit-risk ratio