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    Aug 09, 2021 · ISO 13485, the ISO standard for medical device quality management systems, can help manufacturers to streamline QA processes, improving their effectiveness and potentially reducing costs.

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    ISO 13485 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.

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