Services
Regulatory Affairs
- Preparation of regulatory submissions for class II, III and IV medical devices
- Submission support during Health Canada review
- Regulatory dossier assessment and review
Quality Assurance
- Create and implement Quality Management system in accordance with ISO 13485
- Conduct In-Depth Process Review and Fill in gaps in existing processes
- Promotion and awareness of regulatory and customer requirements
- Internal Auditing
- Review and evaluate Management Review Records
- Review CAPA generated from
- Internal Audits
- Supplier control
- Complaint management
- Management of document control
- Draft quality assurance policies and procedures
- Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
Administrative & Support Services
- Coordinate and direct support services to organizations
- Manage services that allow organizations to operate efficiently, such as:
-Administration
-Customer Service
-Contract Administrator
-Sales and Marketing support
-Records management
