The coming into force of the Medical Device Regulation (MDR) in 2021 has increased scrutiny of technical documentation to warrant the performance and safety of medical devices sold in the EU.
Preparing clinical evaluations which meet not only the MDR and associated MDCG guidelines as well as MEDDEV 2.7/1 requirements is our daily business.
This includes:
- a comprehensive state-of-the-art literature search which covers the products and intended use as well as diagnostic and therapeutic alternatives
- a clinical evaluation plan (CEP) which includes specified clinical outcome parameters as well as quantitative and qualitative aspects of clinical safety and a clear strategy for the clinical evaluation
- a clinical evaluation report (CER) demonstrating compliance of your products with the relevant general safety and performance requirements with data from pre-clinical testing to full clinical studies, including database searches as well as data from similar devices where applicable
With us you get the expertise of our whole team, not a single specialist. Our team consists of people from different backgrounds and includes a variety of skills. We combine knowledge from medical technology, medicine, and medical writing to offer the best processing of your clinical evaluation – in a simple but excellent way.
Escentia works within all stages of clinical evaluations, from the clinical evaluation plan to the finished report.
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Get in contact to find out how we can help your team.
