Services overview

The development, manufacturing and marketing of medical devices must meet legal and regulatory requirements ensuring that the safety of patients and hospital staff is guaranteed at all time. In Europe, medical devices are regulated by three EU directives:
  • 93/42 directive : medical devices in general
  • 90/385 directive : active implantable devices 
  • 98/79 directive : in vitro diagnostic devices
The development of medical devices must result not only in a reliable and validated device but be fully documented in a technical file or a design dossier demonstrating the compliance with all applicable regulatory requirements. The processes for design, industrialization, manufacturing, marketing and monitoring market feedback must be covered by a Quality Management System that ensures at all time compliance with specified requirements.

Medidee provides the necessary support to speed-up regulatory at all steps of the lifecycle of a medical device. Medidee is a reliable partner for successfully bringing products to the market.

Routinely, investors rely on Medidee expertise for conducting regulatory due diligence and project management to make sure that reality meets expectations.