Clinical Evaluation
Experience an all-encompassing Clinical Evaluation Service meticulously designed to comply with stringent global standards like the MDR 2017/745 or Guidance n° 31 of 2020 – version 2 for medical devices.
This service delves into a multi-faceted approach, starting with a comprehensive clinical evaluation plan (CEP), robust literature searches to draw up the State of the Art and to obtain clinical data. Throughout the process, every aspect of the device is closely examined, ensuring that no stone is left unturned. Taking advantage of all this, our experienced specialists draw up a critical and detailed clinical evaluation report (CER). This report serves as a reliable testimony to the safety and performance of your medical device, offering invaluable insights and conclusive evidence of its effectiveness.
Our Clinical Evaluation Service is more than just a review; it’s a testament to our commitment to quality, safety, and transparency in the world of medical devices. It’s about ensuring that every device we evaluate not only meets but exceeds industry standards.
With our service, rest assured, your medical device will stand up for any scrutiny it faces. Trust us to provide you with an evaluation that is thorough, impartial, and completely in line with rigorous global guidelines and regulation (e.g. MDR 2017/745, Guidance n° 31 of 2020 – version 2, FDA and Health Canada).
This is a service that not only safeguards your product but also fortifies its credibility in the medical marketplace. With us at your side, step confidently into the future of healthcare.
Why do you need this service?
We support in setting up a compliant and robust technical file that fulfills all requirements of the MDR 2017/745 Annex II. You have already a technical file but needs an update? We are here to help.
You have difficulties to identify which general safety and performance requirements are applicable? Leave it with us. Our experts will guide step by step.
Your product is already on the market. Do you know which post market requirements need to be met? Don’t worry. We support with the proper planning and define the most appropriate post market reporting. This ensures your technical file will stay up-to-date.
