iso 13485 audit (2)

ISO 13485: Audit Criteria and Certification Process

ISO 13485 is a globally recognised standard that defines the standards for a quality management system (QMS) in the medical device industry. It specialises in the design, development, production, inst...
17 January 2024 ·
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· 1 · smithnicol

What are the ISO 13485 Audit Requirements

In simple terms, an ISO 13485 audit is a review of your business to determine whether it complies with contemporary standards for medical device quality management. A quality management system (QMS) i...
13 September 2023 ·
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· 1 · john