Regulatory and quality expertise for manufacturers entering Canada, the US and the EU.
Medical device regulatory and quality consulting for manufacturers, importers and distributors: Health Canada market entry, ISO 13485 and MDSAP readiness, EU MDR remediation and FDA strategy. Based in the Greater Toronto Area, working in English and French.
The CUE Review
One gap assessment across Health Canada, FDA and EU MDR.
Three regulatory pillars, with Canada at the centre.
All servicesClassification, the MDL lifecycle, Health Canada correspondence, ISO 13485 and MDSAP readiness, MDEL consulting support.
Gap assessment, technical documentation, clinical evaluation, PMS and responses to Notified Body nonconformities.
Regulatory strategy, classification, 510(k) preparation and QMSR alignment with ISO 13485. Consulting role only.
Who we work with
Ontario importers, distributors and manufacturers
From Oakville and Mississauga to Hamilton and Toronto. Licensing, MDEL questions, ISO 13485 and MDSAP readiness, close to home.
Working in Ontario and the GTAManufacturers outside Canada
For manufacturers in Taiwan, India and elsewhere who need a Canadian medical device licence and a clear view of what Health Canada expects.
Support for international manufacturersManufacturers stuck on EU MDR
Open nonconformities, a stalled certification, or a technical file that keeps coming back. We help you find the gaps and prepare the responses.
EU MDR remediationKnow the market before you file.
Regulatory and market intelligence reports built from public Health Canada, FDA and EU data with our in-house tools. Use one on its own, or as the first step of an engagement.
Every report cites its sources and the date the data was pulled, and states the coverage limits of each database.
- Health Canada MDALL
- MDEL listing
- openFDA
- FDA 510(k)
- EUDAMED
- ClinicalTrials.gov
Report types
- Canadian market-entry scanIs a comparable device already licensed, who holds the licence, how crowded is the category.
- US-to-Canada gap analysisFDA-cleared devices in a category with no Canadian licence.
- Importer and distributor landscapeLicensed MDEL establishments by activity and device class.
- Pathway fit checkLikely classification and route in each market, CE mark and EUDAMED presence.
- Competitor and predicate landscape510(k) clearances, ClinicalTrials.gov and patent activity.
- Regulatory change briefsWhat changed, who is affected, what to do next.
How an engagement can start
Free snapshot
One device category, one page, built from public data and reviewed by hand. Target turnaround: two business days.
Full intelligence scan
The complete device list, licence holders, establishment checks and pathway notes for your category.
Consulting engagement
Classification, submissions, QMS readiness or remediation, scoped around your device and your target date.
Latest insights
Technical ArticleWhich FDA-cleared devices have no Canadian licence?
How we compare FDA 510(k) clearances with Health Canada's active licence listing to find devices cleared in the US but not licensed in Canada, and where the method stops.
Read the articleGuideMDEL explained: who needs one and what Health Canada looks at
Who needs a Medical Device Establishment Licence in Canada, who is exempt, how it differs from a device licence, and what it takes to keep one active.
Read the articleAll insightsTell 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