Safely approve your medical device with MDR-compliant clinical evaluation

The clinical evaluation in the MDR

The clinical evaluation is an ongoing process both during development and after the medical device has entered the market. The clinical evaluation aims to demonstrate the safety, performance and clinical benefit of the medical device. To do so, the clinical evaluation systematically collects and evaluates all available information.

The clinical evaluation documents (= clinical evaluation file) are an essential part of the technical documentation of the medical device. Data from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) bring them up to date.

How we can support you

We can help you to prepare the clinical evaluation file so that your medical device receives regulatory approval quickly.

Our Clinical Evaluators:

• assess whether and to what extent a clinical trial is necessary before approval
• prepare a clinical evaluation plan (CEP), which serves as important decision supporting the clinical and regulatory strategy
• document the literature search in a fully comprehensible manner as a basis on which you can further develop your clinical data situation
• demonstrate which claims you are allowed to make and how you can scientifically prove them (Scientific Marketing)
• fulfill the general requirements for the author with the involvement of medical expertise
• initially list and perform the PMCF activities required by the MDR.

We give you everything you need to meet the regulatory requirements of the MDR and MEDDEV 2.7/1 rev. 4 for the clinical evaluation and thus, pass your audit and approval with 100% confidence.

Why it makes sense to let us help you

With our support, you will

• avoid unnecessary clinical trials
• receive important input for potential further or new developments through regular observation of the state of the art
• have early and regular assessment of clinical risks as input for the risk analysis
• save time and costs if information, which are often researched individually, is collected systematically and bundled and evaluated in the overall picture
• implement the process of clinical evaluation and the interfaces in the QM system in a targeted manner