MedCare Medical Devices Canada is a regulatory consulting firm. 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.
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
Company Details
- Employees
- 3
- Founded
- -
- Address
- Vaughan, Ca
- Industry
- Hospitals And Health Care
- NAICS
-
Health Care and Social AssistanceSocial Assistance
- Website
- https://MedicalDevicesCanada.com
- Keywords
- rapid diagnostics, remote medicine, hard surface disinfectant, regulatory consultant, Health Canada consultant, FDA, Health Canada, MDL, MDEL, MDSAP.
- HQ
- Vaughan
Medcare Medical Devices Canada Questions
Medcare Medical Devices Canada's website is https://MedicalDevicesCanada.com
Medcare Medical Devices Canada's LinkedIn profile is https://ca.linkedin.com/company/medical-devices-canada
Medcare Medical Devices Canada has
3 employees.
View email and phone details for 3
employees at Medcare Medical Devices Canada.
Medcare Medical Devices Canada's industry is
Hospitals and Health Care
Medcare Medical Devices Canada's top competitors are
Emrn Medical Equipment,
Staradiance Medical Supply,
Accelera Pharma,
Opencell Biomedical,
Medtronic,
Medcare Health Advisors,
Mdl Education Consultant Ltd,
Boston Scientific,
Medcare Health System,
Medcare Equipment Company, Llc.
Medcare Medical Devices Canada's categories are Hospitals and Health Care
Medcare Medical Devices Canada's founding year is 2019
