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SaMD / AIaMD

Software and AI medical device market access

Route-to-market strategy for SaMD and AIaMD products, including intended purpose, classification, claims, evidence planning and launch sequencing.

SaMDAIaMDMarket access
Vibrant abstract architecture suggesting structured routes through regulated markets.

Service detail

Turn regulatory uncertainty into a credible path from prototype to UKCA, CE, FDA or international market access.

Who this is for

  • Founders building software that diagnoses, monitors, predicts, triages, treats or supports clinical decisions.
  • AI health-tech teams trying to understand whether claims, intended purpose or model behaviour create medical device obligations.
  • Scale-ups preparing to enter the UK, EU, US or multiple markets with one coherent evidence strategy.

Typical client problems

  • The product looks like health software, but the regulatory classification is uncertain.
  • The company is making commercial claims before the evidence strategy is mature.
  • Clinical, software, risk and AI governance evidence are being built in separate workstreams.

What Neural Vibe does

  • Clarifies intended purpose, target users, claims and regulatory classification.
  • Maps the fastest credible route to UKCA, CE, FDA or international market access.
  • Builds a staged evidence plan that aligns product, clinical, software, risk and quality work.

Deliverables

Practical outputs, not vague advice.

SaMD or AIaMD classification rationale

Claims and intended purpose review

Market access roadmap

Evidence gap assessment

Submission and assessment readiness plan

Route

The pathway Neural Vibe manages.

01

Define the product boundary and intended medical purpose.

02

Confirm classification and route-to-market options.

03

Prioritise evidence that unlocks the next commercial milestone.

04

Coordinate technical, clinical, software and AI governance workstreams.

Standards and regulations

Frameworks this work can cover.

UK MDR 2002EU MDR 2017/745FDA SaMD guidanceIMDRF SaMDISO 14971IEC 62304EU AI Act

Related thinking

Read next.

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.

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.

Perspective

Regulatory capability without the corporate machine

A practical operating model for startups that need serious compliance thinking before they can justify a large internal team.

Relevant expertise

Specialist capability around this work.

Expertise

SaMD regulatory strategy

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

Expertise

AI governance and EU AI Act

AI risk, human oversight, model monitoring, ISO 42001 and EU AI Act readiness for health technology teams.

Expertise

FDA and international submissions

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

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