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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?

We have not yet identified the Economic Operators

We know who the Economic Operators will be

They are approved suppliers

They are subject to audits as defined in our supplier approval process

2

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

We have no PRRC yet

We have identified our PRRC

All the qualification information is available and an agreement has been signed

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?

Not yet

This information is gathered in our post-market process

We also have a PSUR process

The PMS and PSUR processes are fully integrated

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)?

No

There is a procedure for unannounced audits

This procedure is notified to all sites and economic operators via quality agreements

5

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

No, we have not identified a qualified NB yet

We have requested timings from our chosen NB

The timetable has been agreed but our Technical Documentation is not yet ready

All is agreed and the documentation is ready for review

On the basis of this sample of questions, you are progressing well toward being compliant. If you would like to see how PharmaLex can deploy the full SMARTMDR engine, please reach out to us to see how we can help.
Print

On the basis of this small sample of questions, there may be some gaps remaining in your compliance and we recommend that you seek further advice. PharmaLex can assist you by deploying the full SMARTMDR engine to give you a more complete picture of what needs to be done to remain compliant on your Medical Device Regulatory journey. Please reach out to us to see how we can help.
Print

On the basis of this small sample of questions, we strongly recommend you take immediate actions to continue commercializing your products under a monitored process. PharmaLex can assist you by deploying the full SMARTMDR engine to give you a more complete picture of what needs to be done to remain compliant. Please reach out to us to see how we can help.
Print

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