Risk Analysis

While reaching the intended performance of a medical device, technical evaluations such as safety, risk and usability should be made and all possibilities that may occur for the patient and the end user should be evaluated. Although risk assessment can be carried out through many standards and guidelines, it would be appropriate to carry out it for medical devices by taking into account EN ISO 14971 and with the help of guide documents ISO/TR 24971, IEC 60812:2018, EN 62366 and throughout the life of the medical device as well as all processes.

In this context, we carry out your risk assessment studies within your technical documentation or separately according to your requirements.