The CUE Review
One gap assessment across Health Canada, FDA and EU MDR. CUE stands for Canada, US and EU. It shows what your existing documentation already covers in each market, where it falls short, and the order in which to close the gaps.
Frameworks covered
- Health Canada
- FDA
- EU MDR
What the review covers
- Classification in each market
- Your device’s likely class and route under each system, side by side.
- Quality system
- Your QMS against ISO 13485, MDSAP and the QMSR, with the market-specific gaps called out.
- Technical and clinical evidence
- Which test reports, risk files and clinical data support each market, and where more is needed.
- Labelling and language
- Market-specific labelling content, including English and French for Canada.
- Post-market obligations
- Problem reporting, recalls and post-market surveillance across the three systems.
- A reuse map and a plan
- What can be shared between files, what must stay separate, and a prioritized plan tied to your target dates.
Situations we help with
- You are planning entry into two or three of these markets and want one view instead of three.
- You hold approval in one market and want to know how much of that work transfers.
- You need a realistic sequence for the next twelve to eighteen months.
Our role
The CUE Review is a consulting gap assessment. It does not produce a single dossier that satisfies all three markets; each regulator has its own requirements and each submission is prepared separately.
Common questions
Will one set of documents work for all three markets?
No. Much of the underlying evidence can be reused, but each market has its own submission format, classification rules and specific requirements. The review shows exactly what can be shared and what cannot.
What do we receive?
A gap table for each market, a reuse map across the three, and a prioritized plan. We walk through it with your team.
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