Our expertise
Regulatory and quality consulting for medical device manufacturers, importers and distributors. Canada first, then EU MDR and FDA, with market intelligence supporting each.
Canadian market entry and compliance
Classification, medical device licences, Health Canada correspondence, ISO 13485 and MDSAP readiness, internal audits, mock inspections, CAPA, supplier qualification and MDEL consulting support.
EU MDR remediation
Gap assessment, technical documentation, clinical evaluation, post-market surveillance and responses to Notified Body nonconformities.
FDA support
Regulatory strategy, classification, 510(k) preparation and QMSR alignment. Consulting role only.
The CUE Review
One gap assessment across Health Canada, FDA and EU MDR.
International manufacturers
Canadian regulatory support for manufacturers based outside Canada.
Regulatory and market intelligence
Reports from public Health Canada, FDA and EU data. Start with a free one-page snapshot.
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