Medical Devices
Medical Devices include products ranging from toothbrushes to cardiac pacemakers. Many must be registered with Health Canada prior to their sale in Canada. Here are some ways we can help:
Regulatory Affairs
- Correctly classify a product (Class I to IV)
- Prepare registrations to Health Canada
- Assist with product importation to Canada
- Prepare applications for Medical Device Establishment Licenses
Labeling and Marketing Compliance
- Review product label and packaging for compliance
- Harmonize packaging for global marketing
- Assist with label and text development
- Advise on advertising claim compliance that is maximized to give competitive edge
- Provide preemptive action guidance for border crossings
Quality Assurance
- Conduct audits for Medical Devices
- Prepare and review Standard Operation Practices (SOPs)
- Manage consumer complaints and Adverse Reactions and report to Health Canada
Due Diligence
- Analyze all technical and scientific aspects of products
Consumer Research
- design and conduct concept and product acceptance tests
- Interpret existing research data
- Conduct focus groups
Claim Substantiation
- Design and commission studies pertaining to product performance
- Review existing clinical or scientific data in support of packaging or advertising claims