Internal Audit MDR 2017/745 IVDR 2017/746 EN/ISO 13485:2016
Regulatory Compliance MDR 2017/745 IVDR 2017/746 EN/ISO 13485:2016
Classification of Medical Devices / Conformity Assessment (route to CE mark)
QMS: Quality Manual / SOP’s / Quality System Form’s
Design History File DHF / Design Input & Design Output, Design Verification, Design Validation (Clinical Studies), Design Transfer
Risk Management File – Risk Management Plan, Risk Assessment, Risk Mitigation, Risk Management Report
Medical Device File – (previously DMR)
Device History Record – DHR
Post-Market Surveillance PMS/ Post-Market clinical follow up PMCF
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