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Get ISO 13485:2016 certification to enhance your medical device quality management, ensure compliance, and boost customer confidence.
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What is ISO 13485:2016?ISO 13485:2016 is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in the design, production, and distribution of medical devices.Who should consider ISO 13485:2016 certification?Organizations of any size involved in the medical device industry—such as manufacturers, suppliers, and service providers—should consider certification to ensure product quality and regulatory compliance.What are the key changes from ISO 13485:2003 to ISO 13485:2016?Key changes include a stronger emphasis on risk management, more detailed requirements for documentation, and increased focus on the regulatory environment.
I completely agree with the notion of a 'time sink'. art (who develops amazing documents - true until critiqued otherwise) > > -- > Eric Blake eblake redhat com +1-919-301-3266 > Libvirt virtualization library http://libvirt.org…