For a successful market entry, IVD 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.
Our services in detail:
- Supporting the preparation of registration documents (registration master file) for the approval of IVD 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.)
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