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Home > SMARTPHLEX > SMARTCHECK MDR

SMARTMDRSMARTCHECK MDR

Are you ready for the new EU Medical Device Regulation effective in May 2021? 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, why not try our teaser tool below. By completing the five questions below, you will 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, the results will be shown in an easy traffic light appearance and explained accordingly.

If you have any questions, please reach us at contact@pharmalex.com.

To find out how PharmaLex can support your readiness for EUMDR

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1Have the identified Economic Operators been added to the list of approved suppliers and any audit requirements identified?

2Are the professional qualifications and experience of the Person Responsible for Regulatory Compliance (PRRC) recorded and available for review?

3Is 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?

4Are 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)?

5Have you agreed the timetable for review of the revised MDR Technical Documentation with your NB?

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 contact@pharmalex.com 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 contact@pharmalex.com 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 contact@pharmalex.com to see how we can help.
Print

Contact PharmaLex for help to ensure you are ready for EUMDR

CONTACT US
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Digital Health

Are you developing health-related software or smart apps? Do you know if your software or app will be classified as a medical device? And is your product ready to meet the requirements of the new EU Medical Device Regulation (MDR) effective in May 2021? Complete our short questionnaire to learn more and find out what help you will need.

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