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