Clinical Evaluation

Product safety and performance must be verified before placing medical devices on the market. Proof of true clinical safety can only begin after the product has proven itself in pre-clinical studies. In other words, if you cannot prove the safety of the product in a controlled manner in laboratory environments, you cannot proceed to clinically proving the product.

The fact that medical devices are in technology that has been used for many years has led to a lighter transition of clinical research processes until now. With the publication of MDR, the need for clinical studies, which is actually included in MDD, but which does not attract attention because it has not been given much attention, has been put forward in detail.

Since the clinical trial and equivalent device framework for MDR between 2017-2020 has not been fully clarified, questions on this subject have led to confusion and misdirection. Thanks to the MDCG guidelines published after 2020, this confusion has been eliminated and clarified. The issue to be considered here is that in order for a medical device to be clinically shown as an equivalent, all technical knowledge of the equivalent device must be officially owned. However, at the same time, the awareness level (WET/ Well-established technology) of the device provides support and infrastructure to the manufacturer to be exempt from clinical research studies during the clinical evaluation process.

At this point, we support you separately in the pre-clinical, clinical evaluation and clinical trial stages for the clinical evaluation processes. We determine your clinical evidence step by step by revealing the history of the product and your data and support you in the execution of all your clinical activities.