What is ISO 13485?

Although the ISO 9001 Quality System standard can be used by any industry, ISO 13485 is the go-to Quality System standard widely used (and recognized) in the medical device industry. ISO 13485 aims to facilitate global alignment between other medical device regulations such as the United States FDA’s Quality Management System Requirement 21 CFR 820.

ISO 13485 covers ISO 9001 with some additions. Therefore, in order to understand ISO 13485, it is worthwhile to understand ISO 9001 for a high-level holistic view. In essence, ISO 13485 is less flexible than ISO 9001 e.g., in organizational processes.

Have questions regarding ISO 9001 or ISO 13485? Reach out to the Conformity Tech team which can help you with your conformance needs.

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