For a successful market entry, medical device manufacturers should familiarize themselves early with regulatory requirements and country-specific peculiarities.So, don't let valuable time pass, but talk to our experts in Regulatory Affairs in a timely manner. We ensure that your product is approved in the target country at the intended time.Reserve a no-obligation initial consultation now to put our expertise to the test.
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.)