Regulatory

With the entry into force of the new Regulation on Medical Devices MDR 745/2017 , which will have full application starting in May 2020, the entire sector is going through a moment of profound change that requires the detailed understanding of the new obligations to be borne by the manufacturing companies and by the different actors of the system, as well as of the many innovations introduced by the Regulation in terms of training, clinical investigations, and much more.

Thanks to the skills of its collaborators in the field of electromedical equipment and medical devices in general, and thanks to an important network of collaborations, MedTech Projects provides 360° consultancy support on regulatory issues such as:
Regulatory framework of the various Medical Devices and innovations introduced by the MDR with respect to the previous Directives
– Iter of certification , risk analysis , declarations of conformity , etc.
– Relations with Notified Bodies and test laboratories
Training and consultancy for manufacturing companies, distributors / importers, health facilities, etc.

Contact us for more information.