Clinical Evaluation

Clinical Evaluation

What is Clinical Evaluation?

In the legislation of many countries, especially in the European region, a clinical evaluation should be carried out before the medical devices are put on the market. The 2017/745 Medical Device Regulation requires clinical data directly obtained from medical devices whose conformity is evaluated for approval for CE marking. This data can be provided by a clinical trial as specified in the legislation or can be obtained from clinical data obtained after sales. In particular, the data obtained from post-sales clinical follow-up play a critical role in the transition from 93/42 / EC Medical Device Regulation to 2017/745 Medical Device Regulation.

In this context, we have services for the systematic review, selection and evaluation of literature-based clinical data, retrospective or prospective evaluation of clinical data consisting of medical devices, and even for the creation of clinical trial protocols in accordance with the legislation.

For detailed information, you can contact +90 532 397 3043 or mformeci@gmail.com.

SERVICES

TRAINING

ISO 13485:2016
CE Marking
510(k) Fundamentals

SERVICES

TESTING

Biomechanical Testing
Finite Element Analyze