Cambio receives MDR certification for EHR-system and clinical decision support

Cambio’s electronic health record system Cosmic and their solution for clinical decision support (CDS) have now been registered and certified according to MDR, the Medical Device Regulation. This means that the products are approved and CE-marked in accordance with the EU regulation on medical devices, which ensures the safety and performance of medical equipment.

“The MDR certification is an important milestone for us as a company, and I am very proud of the work we have done together at Cambio. The certification is proof that those who use our products can trust that they meet the highest standards for medical devices. It is a reassurance for our customers and, above all, for patient safety. With the certification in place, we can continue to drive development towards a healthier society,” says Tomas Block, Chief Medical Officer at Cambio.

MDR certification ensures that the medical services and products used in healthcare are safe and fit for purpose. The marking indicates that the products comply with the latest regulatory requirements for medical equipment.

About the European Medical Device Regulation (MDR)
The European Medical Device Regulation is a European regulation for medical devices. The purpose is, among other things, to create clearer regulation of software products to ensure that the medical services and products used in healthcare and social care are safe and fit for purpose.

MDR increases the responsibility of manufacturers of medical devices to document the functionality, risks, and clinical performance of their products. Certification according to MDR has been mandatory for all medical devices released on the European market since May 2021.