Clinical Affairs: About the clinical application of your IVD medical device

Clinical Affairs deals with all aspects of the performance evaluation of your IVD medical device. The aim of all activities is to demonstrate that the IVD medical device actually delivers the clinical benefit in practical application that was traded off against the risk in the risk management process. The clinical benefit of the device must be proven by data and observed and confirmed throughout the entire product life cycle.

Already in the initial phase of a device’s development, a systematic literature research in scientific databases should be conducted to prove the scientific validity: On the one hand this serves to ensure that known risks of similar products on the market may be excluded for your device; on the other hand it clearly reveals the present state of the art for your technology. These search results are then seamlessly integrated into your product development requirements. You are already familiar with possible comparable products as well as available clinical data. During the course of the further development process, a performance evaluation is prepared and filed as a central document for technical documentation; it is an obligatory prerequisite for CE marking.


The product is on the market, performance evaluation is all done?

No, because as the manufacturer you must ensure a safe and efficient product throughout the entire product life cycle. There are different possibilities to define suitable post-market performance follow-up (PMPF) activities in the scope of post-market surveillance (PMS) such as participating in ring trials, evaluating defined questions with a statistically significant number of patients, long-term observation of patients, or investigations about known risks in literature. Based on this data you identify possible problems of your product, eliminate them at an early stage and thus increasingly adapt your successor products to your users’ needs.

Get us involved in the planning of your PMS activities at an early stage and benefit from our know-how:

Together we identify the solution that suits you best, realize it promptly and in accordance with applicable regulations and are a competent partner for you and your notified body at any time.
Due to our long-term experience with a diverse variety of devices we quickly find the appropriate strategy for your performance evaluation. The result: a focused development process, an accelerated finalization of the submission file as influencing factors are disclosed early, and a safe and efficient IVD medical device.

Due to our long-term experience with a diverse variety of products, we quickly find the appropriate strategy for your clinical evaluation. The result: a focused development process, an accelerated finalization of the submission file as influencing factors are disclosed early, and a safe and efficient medical device for your company.

Our services in detail

Fit for the future with the Metecon Academy

Each of our workshops and in-house courses provides sustainable knowledge and know-how in the areas of technical documentation, regulatory affairs and QM and is always exactly tailored to your needs.

Our customers use our workshops with our experts:
to keep themselves and their team up to date with the latest knowledge and/or to go into intensive exchange with us and gain clarity in the face of a current challenge about a specific description of objectives and the project strategy.

Through the operation of our own trainee academy, our comprehensive training material is always up to date.

Let us find out together what your team needs!












Workshop topics:

  • Implementation of IVDR for technical documentation and QM
  • Risk management
  • Usability
  • Biological safety
  • Clinical affairs
  • Software
  • Approval
  • Quality management

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