International Approval of medical devices

Gaining approval for medical devices for placing them on the market for the first time underlies special approval procedures. The heterogenous international procedures are ever changing and are becoming ever more extensive. We constantly keep you up to date about the major issues in any medical device technology area.

Regulatory Affairs

Gaining approval for medical devices is complex and quite often also confusing. We bring clarity…


> Regulatory Affairs

Clinical Affairs

Clinical affairs of medical devices requires numerous evidences and evaluations. What we know about it …


> Clinical Affairs

Quality Management

Medical devices are governed by stringent requirements on quality assurance. We know the details …


> Quality Management

Development Excellence

Product development of medical devices is subject to its own rules. We bring light into the darkness …


> Development Excellence