Medical devices: Evolucare obtains MDR certification

9 January 2025
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A major step forward for digital healthcare: Evolucare is now MDR-certified for all its Medical Devices.

We are proud to announce that our portfolio of medical device products has received MDR (Medical Device Regulation) certification. This recognition makes Evolucare one of the first medical software publishers to fully comply with this demanding regulation, marking a decisive step for the future of digital health.

MDR certification: a key challenge for patient safety

The MDR regulation (EU 2017/745), which comes into force in May 2021, aims to enhance the safety, traceability and performance of medical devices in Europe. It imposes strict requirements on manufacturers to ensure reliable and safe products throughout their lifecycle.

At Evolucare, this certification is more than just regulatory compliance. It reflects our deep commitment to innovation, excellence and safe care, values that guide our actions every day.

A demanding course with results to match!

Since 2017, Evolucare has adapted its quality system and all the technical documentation for its medical devices to meet the new requirements. Two major products have been selected by GMED (0459) to lead this process:

  • Evolucare OphtAI (IIa) – Artificial intelligence solution dedicated to ophthalmology.
  • Evolucare Intensive (IIb) – Critical care management solution.
We took up a major challenge by adapting our procedures and involving all our teams in this long-term project. This certification is a real recognition of Evolucare’s expertise and our ability to guarantee the safety and performance of our solutions throughout the entire life cycle of medical devices.
Jean HÉE
Head of Quality and Regulatory Affairs at Evolucare

After a rigorous assessment by GMED (0459), our notified body, certification was officially validated thanks to the excellent work of our teams, with all observations successfully lifted.

Osiris 3.5 and Anesthesia 5.0 included in certification

Obtaining this certification automatically entails certification of our other solutions, including :

  • Osiris 3.5 – The digital french Segur-compliant version
  • Anesthesia 5.0 – Integrating CPA web
  • Medical imaging products

These two products, along with our Imaging products (View and UView), will benefit from MDR CE marking, guaranteeing uniform quality and safety across our entire portfolio.

Evolucare, pioneer of MDR certification in the digital healthcare sector

We firmly believe that technological innovation must be accompanied by a rigorous and reliable framework. MDR certification is not only a guarantee of quality, it is also a strategic lever to support the growth of our solutions on the European market and beyond.
Philippe BLANCO
President, Evolucare

By becoming one of the first medical software publishers to obtain this certification for all its products, Evolucare confirms its position as a pan-European leader in digital healthcare services. This distinction highlights our ability to anticipate regulatory changes and guarantee medical devices that comply with the highest standards.

A lasting commitment to innovation and safety

For over 30 years, Evolucare has been supporting healthcare professionals by providing innovative, secure solutions. This certification is part of our continuous improvement approach and reflects our commitment to putting technology at the service of healthcare.

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