Helping medtech companies comply with EU MDR: A case study

Munich-based software company, Climedo Health, has published a case study with German dental implant company, BEGO Implant Systems.

The five-page report focuses on a joint workshop in which Climedo Health, the BEGO Implant Systems team, and dental professionals, elaborated joint approaches to automate clinical surveys for the EU Medical Device Regulation (MDR). 

Under EU MDR, medtech companies will be legally required to gather data about their products’ performance and safety in the market. The process of obtaining feedback on products is often time-consuming for end users, such as doctors or patients, and so the aim of the two-day expert meeting and workshop between Climedo Health, BEGO Implant Systems, and dentists and implantologists, was to identify ways to make the feedback process faster and more convenient.

Without exception, all dentists and implantologists in the workshop expressed their willingness to participate in the planned clinical survey using Climedo. Dr. Nina Wilkens, clinical affairs manager, BEGO Implant Systems, said: “The participating doctors were convinced by the Climedo system and we are looking forward to using it for our post-market surveillance activities.

“What we particularly like are the ease of use and the flexible options for configuring the clinical surveys. We can make any changes to the input masks ourselves in a very short time, without any necessary support from IT.”

Veronika Schweighart, cofounder and COO at Climedo Health, added: “We’re pleased to have created a solution that will make life easier for both BEGO Implant Systems and the dentists and implantologists.

“Gathering valuable post-market data to continuously ensure the safety and performance of medical devices will be key for complying with the new EU MDR demands. Automating this process can save a lot of valuable resources for medtech companies.”

The case study can be viewed in full and downloaded here.