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ISO 13485:2016 FAQs

Get the expert view on ISO 13485


ISO 13485:2016 sets out the requirements for a quality management system (QMS) specific to the medical devices industry. 

LRQA's medical device technical experts answer some frequently asked questions on ISO 13485:2016, its relationship with other international standards, risk management, outsourcing and the support available for organisations going for certification.

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