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ISO 13485 resources and downloads.

ISO 13485 resources

Lloyd’s Register (LR) is dedicated to helping organisations comply with the stringent requirements of the medical device industry. Our ISO 13485 PDF free downloads and resources help clients understand how to align your organisation with the requirements of the standard, and could work as an ISO 13485 implementation guide towards your certification.

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ISO 13485:2016 Overview

Transition to the new standard must be completed by March 2019, and with that in mind medical device manufacturers are seeking clarification on how to implement the new requirements before that.

ISO 13485
Medical
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