Medical Devices

Regulatory Compliance MDR 2017/745 EN/ISO 13485:2016

Internal Audit MDR 2017/745 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

%d bloggers like this:
search previous next tag category expand menu location phone mail time cart zoom edit close