Who this is for
- Companies expanding from one regulated market into several.
- Teams deciding between FDA 510(k), De Novo or another route.
- Founders who need to sequence expansion without rebuilding evidence from scratch.
International
FDA and multi-market submissions
510(k), De Novo, PMA strategy, Health Canada, TGA, ANVISA and evidence reuse across target markets for medical software, SaMD, AI-enabled products and digital health technologies.
510(k)De NovoANVISA
Service detail
Structure one strong evidence base so it can travel efficiently across jurisdictions.
Typical client problems
- Each market appears to require a different evidence package.
- The team is unsure how to choose between US pathways.
- International planning is happening after the first file has already been built.
What Neural Vibe does
- Maps target market routes and likely evidence reuse.
- Coordinates specialist support for local requirements where needed.
- Sequences expansion around regulatory risk, commercial value, AI or software evidence needs and team capacity.
Deliverables
Practical outputs, not vague advice.
Multi-market regulatory roadmap
FDA pathway assessment
Evidence reuse matrix
Submission readiness plan
Specialist coordination plan
Route
The pathway Neural Vibe manages.
Prioritise target markets and commercial timing.
Assess route options and evidence overlap.
Build one core file with local adaptations planned in.
Coordinate local specialists and submission milestones.
Standards and regulations
Frameworks this work can cover.
FDA 510(k)De NovoQMSRHealth CanadaTGAANVISAMDSAP
Start here
Let's turn this into your route to market.
Bring the product, the target markets and the questions. Neural Vibe will map the practical next step.
Book a discovery call