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  • Common Audit Findings for ISO 13485

    In this whitepaper two of LRQA’s quality experts discuss the audit findings for ISO 13485 and how organisations can benefit from a medical device certification.

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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 13485:2016 Gap Analysis Factsheet

    Our factsheet explains how a gap analysis can help you focus on high risk or weak areas of your medical device QMS ahead of your formal assessment visit.

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  • Remote Auditing FAQs

    In this FAQs document, Ron Crooks, Assessment Manager for LRQA addresses your concerns and answers most common questions about remote auditing.

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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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  • ISO 13485:2016 Overview Guide

    Want to achieve medical device QMS certification but don’t know where to start? Download this guide about the requirements and steps to ISO 13485 certification.

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