SMARTMDR Teaser Tool

Are you ready for the new EU Medical Device Regulation? Our team of Medical Device experts has developed a highly effective tool that can be used to assess a complete MDR readiness of all your products.

To gain an indication of your readiness, take our survey below. Complete five questions and get an understanding of your readiness and determine your state of compliance. Your answers will give you a flavor of how our suite of SMARTCHECK MDR services will help you to transition and continue commercializing your products.  Results are shown in an easy traffic light appearance and explained accordingly.

If you have any questions, please contact us.

Survey

1

Have the identified Economic Operators been added to the list of approved suppliers and any audit requirements identified?

2

Are the professional qualifications and experience of the Person Responsible for Regulatory Compliance (PRRC) recorded and available for review?

3

Is there a robust system to record sales volumes and / or frequencies of device use so that the Periodic Safety Update Reports (PSUR) can be prepared?

4

Are you prepared for unannounced inspections of your sites and those of your economic operators by the a Competent Authority as well as your Notified Body (NB)?

5

Have you agreed the timetable for review of the revised MDR Technical Documentation with your NB?

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