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Monsenso receives ISO 13485 certification | Monsenso

Monsenso receives ISO 13485 certification

Copenhagen, Denmark – 06 September 2016.  Monsenso, a technology leader in mobile health (mHealth) solutions for mental health, announced today that the company was granted the ISO 13485 certification, earlier this summer.

ISO 13485 specifies the quality management requirements for medical devices. This certification ensures that the product in question, consistently meets customer requirements and regulatory requirements applicable to medical devices and other related services.

The certification was obtained due to the support received from the Market Development Fund (MMF) which granted 2.9 million DKK for Monsenso and its partners to obtain the necessary certifications to launch the solution internationally.

With regards to obtaining the ISO 13485 certification, Thomas Lethenborg, CEO at Monsenso, commented “This certification brings us a step closer to position Monsenso as a world-class leader of mHealth solutions for mental health. By 2017, Monsenso will have obtained all major quality certifications in Europe, North America and Australia and will be ready to be commercialised world-wide.”

The Monsenso mHealth solution recently obtained its CE Marking and TGA Certification. The next steps for Monsenso are to obtain the ISO 27001 Data Security Certification, and to become HIPAA and FDA compliant, which is also part of the support granted by the MMF funding.

You can download this article as PDF in English and Danish

For additional information contact:
Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 71 7713
highland@monsenso.com

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