12-02-2024

Almawave is one of the first companies in Europe to have obtained certifications for the use of artificial intelligence in the field of healthcare and medical devices. This further strengthens the company’s position in the healthcare sector, with two prestigious certifications issued by DNV.

The first certification, in accordance with the international standard ISO 13485, certifies the company's management system in relation to the development of healthcare software to support clinical decisions. The second certification, in compliance with the European Medical Device Regulation 2017/745 (MDR), certifies compliance with regulatory requirements related to the design, production, and marketing of medical devices in European Union countries.

“Artificial intelligence definitely has the potential to significantly enhance healthcare efficiency and improve people's quality of life,” commented Valeria Sandei, CEO of Almawave. “However, it’s important that the adoption of new potential technologies in the field of telemedicine always be accompanied by strict criteria aimed at protecting people. The MDR certification, particularly regarding innovative fields like those we deal with, is a lengthy and complex process aimed at ensuring technical and clinical aspects of primary importance.”

The use of artificial intelligence in the field of medical devices could bring multiple and significant benefits to the healthcare system, not only in terms of monitoring patients, but also in the efficiency and quality of the support system and of telemedicine services.