Medical Devices
- FDA GXP compliance services
- Medical Device Regulation (MDR) EU 2017/745 Compliance and Training Programs
- In Vitro Diagnostic Regulation (IVDR) EU 2017/746 Compliance and Training Programs
- CE Mark and International regulatory services
- International product registrations
- ISO 9001, 13485 and 14971, MDR and IVDR compliance
- Quality systems development and training
- Design dossier and technical file development
- Project management services