Medical Devices and Food Supplements

We provide a comprehensive range of services to help you bring your medical devices and food supplements to market, including:

IVDR/MDR consultancy:
We help you understand and comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Device Regulation (MDR).
EUDAMED:
We help you register your medical devices in the EUDAMED database.
Software/Applications:
We help you develop, validate, and audit software as medical devicess.
Clinical trials with medical devices:
We help you design, conduct, and interpret clinical trials for medical devices and food supplements.
Performance assessment:
We help you assess the performance of your medical devices in line with the IVDR/MDR.
Medical device vigilance:
We help you manage the risks associated with your medical devices and food supplements.
UDI-DI consultancy:
We help you implement the Unique Device Identification (UDI) and Device Identification (DI) requirements for your medical devices and food supplements.
Food supplements:
We help you to register your food supplements in the Hungarian market. Along with our Marketing capacity we also help you to reach the market.