iQ-SYSTEM PACS receives MDR Certification

IMAGE receives Certification under the European Medical Device Regulation for iQ-SYSTEM PACS

The wait is finally over! After a long certification process of more than two years, we have now successfully achieved compliance with the Medical Device Regulation (EU) 2017/745 (MDR).

Since March 26, 2024, our medical device iQ-SYSTEM PACS including the components iQ-VIEW, iQ-WEB, iQ-4VIEW and iQ-ROUTER meet all legal requirements of the MDR. As a result, the component-based PACS has been certified by our notified body DNV MEDCERT (0482) as a class IIb medical device.

The corresponding certificate can be found in our Sales Partner Login Area (Sales Partner's Area / Regulatory Certificates / EU MDR (Regulation 2017-745)) for download.

By complying with the MDR, we make sure that we continue to supply our customers with safe software products that are developed under highest quality standards and in accordance with applicable guidelines. This milestone shows that our customers can rest assured that we do everything in our power to contribute to the patients’ well-being and safety.

We look forward to presenting the newly certified iQ-SYSTEM PACS components to you in more detail within the next two months. If you have any questions in advance, please feel free to contact our sales team at insidesales[]image-systems[dot]biz.