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Introduction to ISO 13485:2016

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  • ISO 13485 Factsheet

    Download the factsheet to understand the importance of ISO 13845, the benefits for your medical device QMS and how your organisation can achieve compliance.

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  • ISO 13485 Overview FAQs

    Download these FAQs for insight from LRQA's medical device technical experts into the ISO 13485:2016 quality management system standard.

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  • MDSAP Factsheet

    Download the MDSAP factsheet to learn about the benefits of the program and how your organisation can meet compliance.

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  • ISO 13485 overview FAQs.

    Lloyd Register’s medical device technical experts answer frequently asked questions to address the changes that the ISO 13485:2016 revision has introduced.

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