Medical devices

We provide a comprehensive service starting from the evaluation of the medical device proposal (composition, route of administration, use of the medical device), determining a correct classification of the medical device, ensuring design and development of the medical device, in accordance with current legal requirements, preparation of technical documentation, including clinical evaluation of the medical device and certification of the medical device with or without a notified body, depending on the class of the medical device.

Additionally, we provide service related to post-market surveillance (PMS)  and post-marketing clinical follow up (PMCF).