EU MDR First Aid

Features EU MDR First Aid

An interesting 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.DeliverablesNine 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