Clinical Evaluation

With a clinical evaluation, you as the manufacturer prove the clinical capability of your medical device. In other words: You provide evidence that the product actually delivers the medical benefit you promise in product information material and advertising.

A clinical evaluation is based on clinical data from scientific literature and/or from own data acquired in clinical investigations. It is part of the technical documentation and must be presented for the approval of any medical device regardless of its risk class. In the evaluation process, the benefit expected from the application of the medical device according to its intended use is weighed critically against the results from risk analysis, the state of the art, clinical standards, as well as the knowledge collected from scientific publications.

Performance Evaluation IVD

Within the Performance Evaluation the manufacturer proofs the compliance of the IVD with the essential safety and performance requirements of the IVDR.
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Our aim is not just a one-time set up of your clinical evaluation. We want to put you in the position to keep the documentation of your clinical evaluation up to date in the future across the entire product lifecycle with the lowest possible effort in terms of time and personnel.
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The aim of clinical evaluation

The aim is always to confirm the clinical efficacy and safety throughout the expected lifecycle of the medical device and to verify that the identified risks are justifiable in relation to the clinical benefit.

Clinical evaluation is complex and the process requires a considerable amount of time so that it may only be managed by an interdisciplinary team. Commission our experts with parts of the process or the complete package and we will take care that you can concentrate on your core competencies in the meanwhile. Furthermore, we provide you with suitable strategies to keep your documents up to date in the future with little time and personnel efforts.

Our clinical evaluation services:

Developing literature-based clinical evaluations of the medical device in accordance with MEDDEV 2.7/1 revision 4 for the intended use; for products already available on the market or for pre-clinical evaluations before and during product development. This includes:

  • Planning and conducting scientific and documented literature research,
  • Evaluating current data from scientific literature,
  • Analyzing PMS data,
  • Establishing contact with medical experts,
  • Evaluating the documents and results of clinical investigations.
Supporting in the context of meeting vigilance in accordance with MEDDEV 2.12-1 and of a strategy for developing and updating clinical evaluations across the entire product lifecycle:

  • Ensuring timeliness of the clinical evaluation across the entire product lifecycle by developing suitable processes
  • Preparing suitable templates for literature search as well as for the clinical evaluation plan and report.

Consulting, training and workshops focusing on the MEDDEV 2.7.1 guideline and its implementation in the company adapted to individual processes.