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Home > Digital Health Teaser Tool

Digital HealthDIGITAL HEALTH TEASER TOOL

Are you developing health-related software or smart apps? Do you know if your software or app will be classified as a medical device? Does your product meet the MDR requirements? Complete our short questionnaire to find out what help you need.

Please reach out to us if you have any questions. Contact us at contact@pharmalex.com.

1Any software with a medical intended use could be regulated as a medical device. Have you already qualified your software as medical device?

2Have you already classified all your software and devices under the new 2021 Medical Device Regulation (MDR)?

3If your product is classified as class IIa or higher, have you identified an accredited Notified body (NB) under MDR

4Have you integrated a Quality Management System (QMS) in your company?

5Are you aware that most software will no longer be Class I under the MDR and will require a NB assessment unless the software is already on the market before May 2021, in which case it can continue unchanged on the market until 2025?

According to the answers provided you seem to have a strong knowledge on the new challenges and requirement of MDR 2017/745. 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

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PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
6 Jan

ICH releases revised Q9 guideline

The guideline makes it very clear that the protection of the patient is the primary goal of Quality Risk Management (#QRM) and we protect the patient through assurance of product quality and availability.

Read more: https://www.pharmalex.com/quality-risk-management-ich-q9-revision-published-for-public-comments/

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