Case Report Dental Implant
Our client is a medium-sized, leading manufacturer of dental implants. Our goal was to identify clinical data gaps early on and to get the clinical evaluation through the assessment with as few intermediate steps as possible. This case report describes our approach to early stocktaking in the area of clinical data for implants.
Analysis of the Current Situation: We reviewed the basic clinical data such as intended purpose, indications, target patient groups, and clinical benefit information. This helped us to adjust possible formulations to the MDR requirements at an early stage.
Determination of the Clinical Data Situation: At the beginning, we conducted a thorough analysis of the existing clinical data. These were then compared with the basic clinical data. At this point, with our support, indications or details for which only few clinical data were available could already be put to the economic test.
Determination of Requirements: From a regulatory perspective, the safety and performance of medical devices must be comparable to those of similar products. The data on similar products from the state of the Art were analyzed, and the requirements for the customer’s product were derived.
Our client already had the certainty during the preparation of the MDR certification if they needed clinical data within the framework of clinical studies and if so, which data should be collected. Through our strategic support, economic decisions could be made on a solid basis. This saved both money and time. Internal processes and resources could be planned well.