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Services

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
Bright geometric architecture viewed from above, suggesting international pathway planning.

Service detail

Structure one strong evidence base so it can travel efficiently across jurisdictions.

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.

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.

You leave knowing what is ready, what is weak, who owns it, and what will unlock NHS confidence.

01

Market roadmap

Multi-market regulatory roadmap

A sequenced expansion plan that shows which markets to enter, in what order, and why.

Buyer value

Helps leadership make expansion decisions based on evidence reuse, commercial timing and regulatory risk.

Neural Vibe does

We compare target markets, route options, evidence needs and team capacity to build a realistic expansion sequence.

USCanadaAustraliaBrazilEvidence reuse
  1. 01Prioritise
  2. 02Compare
  3. 03Sequence
  4. 04Launch

Route

The pathway Neural Vibe manages.

01

Prioritise target markets and commercial timing.

02

Assess route options and evidence overlap.

03

Build one core file with local adaptations planned in.

04

Coordinate local specialists and submission milestones.

Standards and regulations

Frameworks this work can cover.

FDA 510(k)De NovoQMSRHealth CanadaTGAANVISAMDSAP

Related thinking

Read next.

Briefing

510(k) vs De Novo: choosing your FDA pathway

How to decide which route fits your device and how to avoid the detours that can cost a young company months.

Report

One technical file, six markets

How to structure claims, risk, software and clinical evidence so entering Canada, Australia and Brazil reuses what you have already built.

Perspective

What the EU AI Act means for medical AI

How high-risk classification interacts with medical device regulation, and the governance founders should build before assessment pressure arrives.

Relevant expertise

Specialist capability around this work.

Expertise

FDA and international submissions

Pathway planning, evidence reuse and specialist coordination for FDA, Canada, Australia, Brazil and multi-market expansion.

Expertise

SaMD regulatory strategy

Classification, intended purpose, claims, evidence planning and route-to-market strategy for software-first medical products.

Expertise

Quality and ISO systems

Lean, audit-ready management systems for ISO 13485, ISO 14971, IEC 62304, ISO 27001 and ISO 42001.

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