Medimaps Group Achieves EU Certification Under MDR

Medimaps Group has received Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio. 
 
“We are very proud to be one of the earliest AI companies to achieve the MDR certification. By successfully navigating the rigorous requirements of the Medical Device Regulation, our company proves its ability to deliver innovative and reliable solutions that meet the highest regulatory standards for the benefit of patients, healthcare professionals and medical business partners,” Medimaps Group Co-Founder/CEO Prof. Didier Hans said.  
 
The new MDR took effect in Europe in May 2021 and represents the most significant change to the European healthcare regulatory framework in decades. The certification ensures that medical device manufacturers meet the most stringent quality requirements in order to commercialize their products in Europe. It upgrades the 93/42/EEC directive certification, which the company has held for years, confirming its solidity and reliability to deliver high-quality products. Through the MDR, Medimaps Group increased the  robustness of its clinical evaluation, technical design, and post-market surveillance.  
 
With this certification, Medimaps Group can continue to supply without interruptions certified TBS iNsight software to its European customers and those in subsequent markets. TBS iNsight is a medical image processing device seamlessly integrated into dual-energy X-ray absorptiometry (DXA) scanners, and/or X-rays and CT PACs systems, used to measure BMD to detect bone fragility in osteoporosis patients. The software  provides deep tech bone texture analysis related to bone micro-architecture and complements BMD measuring and clinical risk factors to refine the management of osteoporosis without further examination or radiation. 

“The MDR framework is of utmost importance as it governs our processes to develop, manufacture, market, and monitor the safety of our products. This is the results of a two-year effort to execute this complex regulatory process, which guarantees the highest manufacturing standards and traceability for our medical software,” Medimaps Group Chairman Meinhard F. Schmidt stated.  
 
TBS iNsight is recommended in more than 30 medical guidelines worldwide and published in over 1,000 peer-reviewed scientific articles. Approved in both Europe and the United States, the product is available in 60 countries worldwide. It benefits from reimbursement in certain countries, including dedicated CPT codes in the United States. 
 
Medimaps Group is a Swiss-based company developing and marketing software as a medical device solutions. Its medical imaging software applications are developed with the patient in mind, and are based on patented multi-purpose technology with artificial intelligence capabilities, providing healthcare solutions that fit seamlessly into the workflow. The company’s lead product, TBS iNsight (Osteo),  has been used for years in clinical practice worldwide in the field of osteoporosis, and is established as the gold standard for bone texture assessment in clinical practice.