Turn regulatory complexity into a clear market pathway. Crossbridge Partners combines regulatory strategy, quality expertise and market intelligence to support medical device manufacturers, importers and distributors across Health Canada, ISO 13485, MDSAP, EU MDR and FDA requirements.
Canada first, with US and EU requirements considered from the outset.
Learn moreIntegrated knowledge across the major regulatory systems for medical devices.
Explore all servicesSee your market before choosing your pathway.
Market Intelligence Snapshot
Your device category
Public data, with the date pulled
Canada
Active licences (Class II to IV)
US
FDA clearances (510(k))
Gap
FDA-cleared, no Canadian licence
Likely route (Canada)
Class IIMDLMDEL (importer)
One cross-market review. Three regulatory systems. A clearer path forward.
Canada-first expertise, with coordinated support across the US and EU.
Classification, MDL lifecycle and Health Canada correspondence, supported by ISO 13485 and MDSAP readiness, internal audits, CAPA and supplier qualification.
Gap assessment, technical documentation, clinical evaluation and PMS support, with structured remediation of certification issues.
EU MDR
technical file
Example layout
Identify gaps
Detailed review against MDR requirements
Remediate
Prepare and update documentation and evidence
Verify readiness
Address Notified Body nonconformities and prepare for certification
Regulatory strategy, classification, 510(k) preparation and QMSR alignment with ISO 13485.
Consulting support only. We do not act as a U.S. Agent.
Regulatory pathway
Quality system
Who we work with
Practical support for medical device manufacturers, importers and distributors across Canada, the US and the EU.
01Canada
Classification, licensing, Health Canada correspondence, ISO 13485 and MDSAP readiness, internal audits, CAPA and supplier qualification.
Explore Canadian market entry02International
We help international manufacturers understand Canadian requirements, classification, licensing and the quality system expectations for market entry.
Enter the Canadian market03European Union
Gap assessment, technical documentation, clinical evaluation and PMS support, with structured remediation of certification issues.
Explore EU MDR remediation04United States
Regulatory strategy, classification, 510(k) preparation and QMSR alignment with ISO 13485 for manufacturers entering or operating in the US.
Explore FDA strategyMarket intelligence
Turn public regulatory data into actionable market intelligence. Crossbridge Partners analyzes Health Canada, FDA and European data to help you understand the market, identify comparable devices, evaluate regulatory pathways and spot potential gaps before committing resources.
Every report identifies its sources, retrieval date and database limitations, so you know what the evidence shows, and what it doesn't.
Public regulatory data
Actionable insights
Report types
Row visuals show report layouts, not results.
How we work
Begin with a focused intelligence snapshot, deepen the analysis when needed, then move into targeted regulatory execution.
01Discover
A focused, one-page view of your device category using public regulatory data, with sources, retrieval date and coverage limitations clearly identified.
02Understand
Go deeper with device listings, licence holders, establishment intelligence, competitor signals and regulatory pathway considerations relevant to your market.
03Act
Turn the intelligence into action with regulatory strategy, classification, submissions, QMS readiness or remediation scoped around your device, market and objectives.
Start where you need us. There is no requirement to complete every step.
Insights
Practical analysis of regulatory changes, market signals and compliance challenges across Canada, the US and Europe.
The documentation, clinical evaluation and PMS gaps behind most EU MDR certification delays, and how to structure remediation before the next Notified Body review.
EuropeEU MDR
Explore the insightHow 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.
US to CanadaMarket gap
Explore the analysisWho 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.
CanadaMarket entry
Read the guideReady to move forward?
Tell us about your device, your target market and where you are today. We’ll start by understanding the regulatory pathway, market considerations and priorities that matter to your next move.