Services
End‑to‑end regulatory guidance for medical device companies entering the Canadian market.
Regulatory Strategy & Consulting
Tailored guidance to navigate Health Canada’s regulatory framework for medical devices — from initial assessment to final approval.
Device Licensing & Registration
End‑to‑end support filing Medical Device Licence (MDL) applications with Health Canada — documentation, submission, and follow‑up.
Compliance & Quality Management
Help companies meet Canadian Medical Device Regulations (CMDR) and quality system requirements — gap analysis, implementation, and maintenance.
Post-Market Surveillance
Ongoing compliance support including adverse event reporting, licence maintenance, and post‑market obligations for licensed devices.
Regulatory Solutions Built Around Your Business
Whether you’re launching a new device or maintaining compliance, we tailor our services to your specific regulatory needs.
Medical Device Manufacturers & Private Label Manufacturers
Seeking Canadian representation and support through the MDL/MDEL process.
Importers & Distributors
Looking to comply with establishment licence requirements.
Regulatory Affairs Teams
Seeking assistance with QMS alignment and post-market activities.