ISO 13485 resources and downloads.

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Find out about the steps that Penlon took before pursuing ISO 13485:2016 certification, key learnings from their transition process and tips for organisations looking to change Certification Body.

More and more medical device manufacturers require suppliers and service providers to be certified to ISO 13485 as a pre-requisite for doing business. Learn more about how to achieve compliance.

LR’s medical device technical experts answer frequently asked questions to support manufacturers with the transition and address the changes that the ISO 13485:2016 revision has introduced.

Experts from Lloyd's Register answer some of the most frequent questions about implementing ISO 13485 and maintaining an effective management system.