Successful approval of medical devices world wide

For successful market entry, medical device manufacturers today should familiarize early with regulatory requirements and country-specific distinctions.

So do not waste any precious time, but contact our Regulatory Affairs experts at an early stage. We make sure that your device is approved in the relevant target country on time as planned.

Different countries, different customs – that is all the more true in the context of certification and market entry. Use our know-how, stay on the safe side!
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Our services in detail:

  • Supporting the creation of registration documents (registration master file) for the approval of medical devices in different countries (Europe (CE), USA (FDA), ...(TGA), MDL, CFDA, PMDA) in accordance with legal requirements,
  • Preparing approval applications for international registration procedures,
  • Accompanying the approval process, planning and preparing change and renewal requests.
  • Researching special regulatory requirements for defined target countries (e.g. UDI, classifications, etc.)