2023 Medical Devices CE Mark for a MDSW (Medical Device Software)

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About this Case Study

The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as a Medical Device. They must comply with the regulatory requirements and obtain the CE Mark for the
commercialisation of the new product in Europe.

To learn more about the successful project and the comprehensive results achieved in obtaining CE Mark compliance, download the full case study now.

Discover the step-by-step process, key improvements, and valuable insights that led to the company obtaining CE mark in a shorter time period.

The company obtained CE marking in less time thanks to Rephine’s global approach to ensure not only the development and validation of the software but also the necessary quality assurance system (QMS).

Download the Case Study