Regulatory Consultant

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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