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ISO 13485

ISO 13485 overview FAQs.

International standard ISO 13485:2016 sets out the requirements for a quality management system (QMS) specific to the medical devices industry. Transition to the ISO 13485:2016 revision must be completed by March 2019, hence medical device manufacturers are seeking clarification on how to implement the new requirements before the deadline.

With that in mind, LR’s medical device technical experts answer some frequently asked questions on the changes that the ISO 13485:2016 revision has introduced to support manufacturers with the transition.

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