Medical devices

Medical devices are fast growing market. A clinical investigation is a study on human subjects, undertaken to assess the safety and/or performance of a medical device. The undertaking of a clinical investigation is a scientific process leading to clinical data.

Pharmnet is prepared to set up and perform a medical device clinical investigation as well as support you in subsequent regulatory steps. We have knowledge of Czech environment of clinical trials with medical devices as well as US pre-market notification (510(k)) and approval (PMA) process.

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