We assist manufacturers from around the world in navigating the Health Canada and FDA regulatory approvals processes, for their innovative medical devices. Our experience ranges from Point Of Care testing and diagnostics, through to mobility devices and Telehealth products. Service Offering Overview:
Regulatory Consulting for Health Canada and U.S. FDA
- FDA and Health Canada Regulatory Services
- Regulatory and Classification Research and pre-submission
- Medical Device Classification and Licensing
- MDL, MDEL, MDSAP Program Compliance Services
- Protocol Building and Submission (Clinical Trials)
- Ethics Board Applications
- MDEL Utilization For Importation of Medical Devices
- Document Preparation and Submission
- Regulatory Correspondent on behalf of Manufacturer
- Product Development Services
- Product Quality Control Services
- FDA Product Registration Management
- FDA ISO-13485 Certified Manufacturing Services
- FDA 510(k) Generation, Review, and Submissions
Importation and Logistics
- Importation and Logistics Coordination
- Customs Regulatory Consulting
- Customs Clearance and Declarations
- Ground/Air/Sea Transport
- Local Courier
