About Crossbridge Partners
A medical device regulatory and quality consultancy based in the Greater Toronto Area. We help manufacturers, importers and distributors enter the Canadian, US and EU markets and stay compliant once they are there.
Lead consultant
Name withheld. Full CVs available under NDA.
Lead consultant profile
Lead consultant at Crossbridge Partners. Regulatory and quality professional working across Health Canada, MDSAP, ISO 13485 and EU MDR, helping manufacturers, importers and distributors enter markets and stay compliant.
Builds in-house regulatory-intelligence tools on public Health Canada, FDA and EU data, including cross-market comparisons of licensed and cleared devices. Based in the Greater Toronto Area, working in English and French.
- Health Canada
- MDSAP
- ISO 13485
- EU MDR
- FDA strategy
- Regulatory intelligence
Full CVs available under NDA. Ask through the contact form.
How we work
One point of contact
Every enquiry and every contract goes through Crossbridge Partners, so you always know who is responsible.
Consulting, not certifying
We consult, prepare, review and coordinate. We do not certify, approve, or act on your behalf before a regulator.
Sources you can check
Advice and reports cite the regulation, guidance or database behind them, with dates.
English and French
Meetings, documents and correspondence in either language.
Independence
Crossbridge Partners is independent. It is not affiliated with Health Canada, the FDA, the European Commission or any Notified Body. Client names, audit findings and regulator or Notified Body correspondence are never published without written permission.
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