TPIreg now provides a full suite of services for the medical device sector. Our team of experts have extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, urology, wound care, dentistry, infection control, and oncology. TPIreg can guide you through the following:

  • Strategic Regulatory and Compliance Consulting Advice
  • Agency Meetings (Pre-ITA, Pre-Submission and Appeal meetings)
  • Product Classification/Licence applications for Medical Devices and IVDs
  • Review and Verification of Safety and Efficacy Evidence in Support of Device Licences
  • Companion/Combination Product Requirements
  • Applications for Test Kit Numbers (Controlled Substances)
  • Investigational Testing Application (ITA) Guidance and Submissions
  • Quality systems to meet ISO 13485 (MDSAP); internal and supplier audits
  • Medical Device Establishment Licence applications for importers and distributors (MDEL)
  • Market Access Consulting (through InnomarConsulting™)
  • Reimbursement Strategy

To find out more about how our team at TPIreg can help you, please call us at 905-847-4310 or email us at .

Therapeutic Products Inc. (TPIreg) – a boutique Canadian consulting firm offering regulatory and quality assurance services to the pharmaceutical and healthcare industry in North America.