What is Required for Effective Control of Documents under ISO 13485?

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2025-08-18 10:19:44 - Translate -

In the highly regulated medical device industry, maintaining proper documentation is not just a compliance requirement but also a critical factor in ensuring product safety and quality. ISO 13485, the international standard for Quality Management Systems (QMS) specific to medical devices, emphasizes strict control of documents to meet regulatory and customer requirements. Effective document...

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