Regulatory & Market Access
Overview
We support our MedTech clients with thousands of medical device and IVDs projects:
- Building Technical file.
- Leading the risk management activities.
- Leading Design and Development process.
- Registering their products globally.
- Leading the certification process for CE mark, FDA approval and global market access.
US FDA 510(K) for Medical Devices & IVDs
CE Mark EU MDR 2017/745 & EU IVDR 2017/746
