Medical Devices / Combination Products

Challenging tasks require exceptional solutions. Many years of experience and expertise enable GCP-Service to offer a well-trained expert team providing clinical research and regulatory services for all kinds of medical devices and drug-device combination products. GCP-Service is one of the few CROs worldwide offering services for medical device studies.

With the amendment to the EU Medical Device Directive MDD 93/42/EEC, the requirements for performing clinical studies for supporting data have been implemented. If you need clinical data for your product, you need an experienced partner. GCP-Service offers services regardless of whether a CE marking is intended or is already placed, whether a class I or a class III device, whether in Europe or in the rest of the world.

The development of combination products, utilising the physical benefits of medical devices together with the pharmaceutical effects of drugs, will be one of the great challenges of the current century. However, medical devices and pharmaceuticals are from extremely different worlds in terms of history, philosophy and regulations. To successfully combine these, you have to draw on expertise from both worlds. GCP-Service offers this: if you need support to develop your product, please contact us. We are here to support you!

We have conducted studies with medical devices or combination products in following indications:

  • Acne
  • Bladder cancer
  • Cervical cancer
  • Cervical degenerative disc disease
  • Chronic obstructive pulmonary disease (COPD)
  • Colon cancer
  • Cruciate ligament rupture
  • Dermal filler
  • Diabetes mellitus
  • Geographic atrophy
  • In vitro diagnostics (IVDs)
  • Mitral valve regurgitation
  • Primary resurfacing arthroplasty
  • Retinitis pigmentosa
  • Shoulder hemi arthroplasty
  • Thoracic adolescent idiopathic scoliosis
  • Ulcerative colitis
  • Wrinkles