Regulatory affairs medical devices registration consulting services Poland
We offer you authorization (registration) of medical devices in Poland and surrounding countries according to medical device class and type, preparation of proper labelling according to local law as well as medical devices consulting. We can also help you with preparation of technical dossier and getting CE mark from notified bodies.
Medical devices are classified on the basis of composition, construction and method of use into several categories: active implantable medical devices, in vitro diagnostic medical devices and general purpose medical devices. Conformity assessment of medical device, necessity of assessment by notified body as well as medical device autorization (registration) process depend on type and class of the device.