Experienced, Personal Consulting
Bridging the gap between client and compliance!
About Us
Medical Devices
Regulations and Compliance
Regulations and Compliance
Quickgistix Consulting Ltd. is a regulatory affairs and quality assurance consulting firm that provides regulatory solutions to companies who wants to import, distribute, manufacture and/or market healthcare products in Canada. Through extensive experience working with Health Canada and working with affiliates who bring additional expert
Quickgistix Consulting Ltd. is a regulatory affairs and quality assurance consulting firm that provides regulatory solutions to companies who wants to import, distribute, manufacture and/or market healthcare products in Canada. Through extensive experience working with Health Canada and working with affiliates who bring additional expertise on special projects by providing and developing regulatory strategies, Quickgistix obtains optimal product approvals and facilitates successful market launches for medical devices.
Regulations and Compliance
Regulations and Compliance
Regulations and Compliance
We oversee several regulations in the Medical Device industry namely, Medical device licenses submissions through Health Canada, Upholstered and stuffed articles registration through TSSA regulations, Electrical safety compliance support.
Personalized Client Focus
Regulations and Compliance
Personalized Client Focus
We work with small, medium and large companies. Every project and every client is treated uniquely, and with confidentiality in all of our work.
Services
Regulatory Affairs
Regulatory Affairs
Regulatory Affairs
- Assess new products for regulatory compliance
- Labeling and advertising review for compliance
- Medical device application submissions
- Product review and feasibility
- Product submissions and government filings
- Upholstered and stuff articles review and registrations
- Electrical safety product compliance review
Quality and GMP
Regulatory Affairs
Regulatory Affairs
- Audit preparation and follow-up
- Electrical safety reviews and registrar selections
- ISO registrar selection, implementation and support
- Medical Device Establishment Licensing support
- Recalls and complaints support
- SOP implementation
- Health and Safety review and support
Trademarks
Regulatory Affairs
Trademarks
- Basic Trademark search
- Preparation of Trademark application
- Filing of Trademark application with CIPO electronically
- Review for technical issues related to trademark application
- Follow up with Examiner report