Qserve EU MDR First Aid

Qserve's hulpmiddel voor fabrikanten van medische hulpmiddelen op de weg naar EU-MDR compliance.

A tool for medical device manufacturers involved in the European regulations with a questionnaire based on the key changes in the new European Medical Device Regulations (MDR). The outcome of the questionnaire gives basic insight in your position, marked as a (part of) 100%, on the road to EU-MDR compliance and that of the other medical device manufacturers using this application.

Deliverables

Nine sections are covered, and include relevant questions per section. A simple yes or no will lead you through the whole questionnaire. Finally, a graphic per subject will be displayed, with a 100

% score reflecting control of changes, and N/A score not influencing your current status. In case the subject is applicable and you did not score the maximum 100%, a few suggestions are given about where to focus and how to act to master this change.

Key changes covered

• Scope & Classification

• Notified Bodies

• Conformity Assessment

• Supply Chain Control

• Safety and Performance Requirements

• Clinical Data & Equivalence

• PMS & PMCF

• Traceability & Registration

• Liability