The ideal approval strategy for your medical device

Your approval strategy is the most important prerequisite for entering the market successfully. Although harmonization efforts are underway worldwide, medical device manufacturers must familiarize intensively with the approval specifics of each country; costs and time to market are also important factors that must be considered.

Our Regulatory Affairs team provides comprehensive advice on country-specific approval requirements, supports you with implementing them, and make contact with your official bodies – for successful approval within the intended timing. We look forward to getting to know you!

What we can do for you:

  • Researching and training national and international regulations, process guidelines, and principles,
  • Ensuring regulatory compliance:
    • Analyzing (inter)national legal requirements as well as developing and advancing appropriate approval strategies,
    • Establishing and maintaining contact to national and international regulatory authorities, certification bodies, notified bodies, as well as to national and international health authorities,
    • Informing about changes in national and international legislation as well as the underlying scientific and political influences,
    • Answering regulatory questions (e.g. UDI implementation).