Medical device regulatory consulting in Ontario and the GTA
Based in the Greater Toronto Area, we work with importers, distributors and small manufacturers across Toronto, Mississauga, Oakville, Hamilton and the rest of Ontario. Meetings in person or by video call, in English or French.
Frameworks covered
- Health Canada
- MDEL
- MDSAP
- ISO 13485
What Ontario companies usually need first
- MDEL questions
- Whether your activities need an establishment licence, and what your procedures must cover to keep it.
- Checking device licences
- Confirming that the devices you import or distribute hold a valid Canadian licence where one is required.
- Licence applications
- Preparing medical device licence applications for Ontario manufacturers of Class II to IV devices.
- ISO 13485 and MDSAP readiness
- Gap assessments, internal audits and mock audits before certification.
Our role
We consult, prepare and review. Your company holds its own licences. We do not import or distribute devices or hold an MDEL for clients.
Start with a market intelligence scan
Before a regulatory engagement, a scan built from public Health Canada, FDA and EU data shows whether comparable devices are already licensed, who holds the licences, and which route is likely. Every report cites its sources, the date the data was pulled, and the coverage limits.
Tell us about your device and the market you are aiming for.
A first conversation covers the device, its likely classification, where you are today and the date you are working to. Every enquiry goes through Crossbridge Partners, so there is one point of contact.
Discuss your regulatory pathway