During the Clinical Evaluation process, we collect, assess, and analyze the clinical data of your medical device in order to confirm its safety, performance, and clinical benefit.
State of the Art
The requirements regarding performance and clinical benefit requirements of a medical device may change at any time. We are able to support in the State-of-the-Art analysis to ensure that your product meets the high expectations of the clinical community.
Providing a Safety and Clinical Performance Report (SSCP) has been mandatory for manufacturers since the Medical Device Regulation (MDR) was introduced in 2017. We will support you in meeting the increased level of requirement.
We actively monitor the market and develop appropriate Post-Market Surveillance strategies for your medical device. As a result, we can identify possible complications and trends early and improve the overall safety of medical devices, which are already on the market.
Based on the results of the CER, we help you plan your PMCF activities according to MDCG 2020-7. We support your data collection activities and help with evaluating the results for your PMCF Evaluation Report with a special focus on safety and performance.
A carefully-conducted risk analysis can already significantly improve a medical device's safety, as early as the development phase. Consequently, potential risks associated with the device can be recorded and minimized by taking appropriate measures.
Biological Safety (BEV)
As manufacturer you are required to ensure the biocompatibility of your product. Biological risks, e.g. materials that cause allergic reactions, must be minimized. We can help you meet the requirements according to the ISO 10993 standard.
Quality Management (QM)
A sustainably structured and certified quality management system in accordance with ISO 13485 not only helps to control and improve your company, but also to secure it's existence in the long term.
The evaluation process includes clinical performance, analytical performance and scientific validity. This ensures that your medical device meets safety requirements and achieves the intended clinical benefit and complies with the requirements of the IVDR.