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.
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