TPIreg now provides a full suite of services for the medical device sector. Our team of experts can guide you through the following:

  • Product classification and licence applications services for medical devices and IVDs
  • Establishment licence application services for importers and distributors (MDEL)
  • Review and verification of safety and efficacy evidence in support of product licences
  • Companion/Combination product requirements
  • Applications for Test Kit Numbers (Controlled Substances)
  • Investigational Testing Application (ITA) guidance and services
  • ISO 13485 Quality Management Systems Manual and SOPs
  • Preparation for ISO 13485 CMDCAS and MDSAP audits
  • Strategic regulatory and compliance consulting advice

To find out more about how our team at TPIreg can help you, please call us at 905-690-4343 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.