Medical devices must observe the reference standards, in order to demonstrate their safety
and efficiency in the range of action envisaged, before being placed on the market.
Manufacturers and importers are called upon to meet these requirements.
Our laboratories are in a position to accommodate all testing requirements on category I and IIa medical devices which affect the patient directly or indirectly, also during the prevention phase.
Our customers can rely on:
- expertise in the medical sector
- skills and reliability of the technicians, who are involved in continued training schemes
- availability of dedicated testing lines equipped with latest-generation instrumentation
With Regulation (EU) 2017/745 (MDR) coming into force, the European Medical Devices industry will have to face a complex regulatory evolution. The Regulation not only governs the CE marking of Medical Devices more clearly, but it also introduces some significant news in product classification and in the management of the technical file.