Zertifizierungen

General Project has always focused on the quality of its products and the respect for the environment and, since its origins, the company has always committed itself to obtain the relevant certifications: UNI EN ISO 9001, UNI EN ISO 13485, UNI EN ISO 14001.

All GP products, including the ultrasound system Med Contour in all his versions, obtained the CE 0476 certification from the notified body Cermet, according to the European regulations about medical devices.
Besides all that, General Project has always taken care of the registration and certification of its products all over the world.

Med Contour in fact boasts the CSA Canadian approval and the Thai FDA, the governmental authority which rules public health in Thailand.

The device model, produced for the North American market, called MC1, has finally obtained the K091615 510K clearance from FDA, the US severe governmental body.

  • Cermet (PDF)
  • CSA Canada (PDF)
  • Thai FDA (PDF)
  • Clearance (PDF)