Clinical Evaluation

The Medical Device Regulation (EU) 2017/745 (MDR) requires manufacturers to demonstrate the safety and performance of their medical devices through clinical evaluation. We support you in developing a tailored and pragmatic strategy for your device. To achieve this, we create a detailed clinical evaluation plan, analyze available data, and conduct the clinical evaluation. When needed, we leverage our network of recognized clinical specialists across various fields to provide expert input for your specific requirements.

One of our specialized offerings is qualitative clinical evaluation (qCE) for devices where clinical data is available from multiple sources. This evaluation can serve as a foundation for scientific publications.The clinical evaluation is closely linked to other regulatory documents such as the PMCF (Post-Market Clinical Follow-Up) report or the SSCP (Summary of Safety and Clinical Performance). Through a well-designed and coordinated approach, we ensure not only compliance with regulatory requirements but also efficient use of resources. This allows you to save time and costs while providing the necessary evidence for the safety and performance of your medical device.