If you are manufacturing IVDs included in the Annex II List A or B or for self-testing, the CE marking conformity assessment will most likely include having a quality management system meeting one of the Annexes of the Directive.
What is known as the ‘Full Quality Assurance System’ in the Directives is broadly equivalent to ISO 13485:2003 ‘Medical devices, Quality management systems, Requirements for regulatory purposes’, with the addition of certain administrative requirements.
GEMAR can help your company achieve certification to ISO 13485 and compliance with the relevant directive Annex, providing audits, pre-inspection reviews, gap analyses and quality system development. Click here to access the Quality Systems section of our website, or contact us for further information.