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ISO 13485 – QMS.4.2.3.1.4 – Essential Requirements Checklist Template – UKCA Marking The Essential Requirements (ER) checklist is a checklist against annex I of 93 42 EEC used to demonstrate conformity with the UK Medical Device Regulations 2002 for the purposes of medical device UKCA marking. The device needs to be assessed against each clause of…
ISO 13485:2016 QMS Template – Checklist Enhance your Quality Management System with our ISO 13485:2016 compliant checklist, expertly crafted by the professionals at Patient Guard. Experienced experts develop our Quality Assurance and Regulatory Affairs document templates, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations. Why Choose…
This comprehensive medical device & IVD risk management ISO 14971:2019+A11:2021 checklist allows you to identify which clauses are applicable to your medical device(s) and input the reasonings behind your decision. It also allows you to input which evidences you have to prove that each clause has been fulfilled. This template should give you a clear…
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