MedApp S.A., a leading pioneer in the field of innovative solutions in AR (Augmented Reality) medical technology, is pleased to announce that our advanced products, CarnaLife Holo and CarnaLife System, have been awarded the prestigious MDR (Medical Device Regulation) certification. This certification was granted by the internationally recognized company TÜV NORD, confirming the highest standards of quality and safety for our medical solutions. 

Receiving the MDR certification is a key milestone in the ongoing growth of our company and a testament to our ability to meet the most stringent regulatory standards. Compared to the previous CE certification, the MDR certification introduces significantly higher requirements for the safety, effectiveness, and quality of medical devices. The process of obtaining the MDR certificate is much more complex and time-consuming, making its acquisition a remarkable achievement. MedApp S.A. is one of the few entities in Poland to have earned this certification, highlighting our leading position in the industry and our advanced approach to quality management. 

Thanks to the MDR certification, our products can now be introduced to the European Union market with the latest applicable certification, which not only confirms their compliance with strict regulatory requirements but also helps and accelerates their sales in this market. Additionally, holding the MDR certificate opens new and significant opportunities for international market expansion. This certification enables our products to be more swiftly and efficiently introduced to markets outside the European Union, where many countries recognize MDR standards as the basis for an expedited or automatic certification process. The countries where the MDR certificate facilitates the introduction of our products include Switzerland, Norway, Iceland, Liechtenstein, Turkey, Australia, Canada, the United Arab Emirates, Saudi Arabia, Qatar, and New Zealand. 

Obtaining the MDR certificate not only strengthens our presence in the European market but also provides a strategic advantage on the global medical scene. It gives our clients and partners confidence that our products meet the highest standards of quality and safety, which are essential in the rapidly evolving healthcare sector. 

MedApp S.A. proudly celebrates this significant milestone as a testament to our determination and commitment to delivering innovative and high-quality medical solutions. We express our gratitude to our employees and partners for their invaluable support, which has enabled us to achieve this major goal. We continue our efforts to provide solutions that contribute to improving health and quality of life worldwide. 

MedApp – Empowering people for better health.