Medical Devices Regulatory Consulting

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.