The industry has developed a wide portfolio of products addressing acute and chronic diseases used by interventional cardiologists, gastroenterologists, general surgeons or emergency specialists.

The development of Minimal Invasive Surgery (MIS) and laparoscopic surgery relies on devices dependant on narrow tolerance and a high level of integration.

Invasive systems include a wide range of systems including ablation catheters, extracorporeal circulation, fluid delivery machines or apheresis equipment.

These devices are usually high-class devices (IIb or III in the EU, II or III in the USA). Also, these products may include an active controller.

Medidee supports Clients with following services:

  • Confirmation of classification as per 93/42 MDD or 2017/745 MDR
  • Planning of Design & Development activities
  • Organization and coaching of risk management as per 14971
  • Setup of clinical investigations and evaluation as per 14155 and MEDDEV 2.7/1 Rev. 4
  • Preparation of a Biological Risk Assessment (BRA) and management of 10993 compliance
  • Review of 60601-1, 60601-1-2 compliance with test labs
  • Organization of software compliance for control units as per 62304
  • Supplier controls, initial capability audits, supplier agreements
  • Production process validation including cleaning and sterilization
  • Regulatory submission for CE marking