Clinical Evaluation: Clinical Evidence for your Medical Device

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

In the Performance Evaluation process, the manufacturer demonstrates by the appropriate means that the IVD placed on the market meets the essential safety and performance requirements of the IVDR.

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Clinical evaluation objective

The objective is always to confirm clinical effectiveness and safety throughout the expected life of the medical device and to verify that the identified risks are justified in relation to the clinical benefits.

Clinical evaluation is a complex and time-consuming process that can only be managed by a multidisciplinary team. If you assign our experts with partial tasks or their entire preparation, we will take the burden off your shoulders so that you can concentrate on your core competences in the meantime. We will also provide you with appropriate strategies to keep your documents up to date in the future with minimal time and manpower.

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.

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