Digital 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.

If you have any questions, please contact us.



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


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


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


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


Are 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?

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