Medical Device Establishment Licence Applications:
We provide the following project management and advisory services to assist Medical Device Companies to comply with Medical Device Establish Licence Requirements and submitting Licence Applications:
- Classification of Medical Devices according to the MCC guideline;
- Guidance on document requirements from international suppliers;
- Compilation of Site Master File and STED documents;
- Implementation of a Basic Quality Management System;
- Skills transfer and training;
- Completion of Licence Application.