SaMD, AI governance, NHS assurance and ISO systems

Together,we clearmarket access.

Support for

Neural Vibe helps health-tech and med-tech providers, healthcare institutions and care providers move from product, selection or deployment to market and adoption - combining regulatory expertise, healthcare AI advisory, NHS digital health assurance and a trusted specialist network through one accountable partner.

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Market access

Route-to-market strategy for SaMD and AIaMD

AI governance

EU AI Act and ISO 42001 readiness

NHS readiness

DTAC, DCB 0129 and buyer evidence

Orchestration

One accountable partner for specialist compliance

Compliance across

UK MDREU MDRUS FDANHS DTACEU AI ActBrazilAustraliaCanada

Choose your route

Start with the pressure you are actually feeling.

The fastest path through compliance is not a catalogue. It is a decision sequence: what are you trying to prove, to whom, and what evidence unlocks the next move?

Market access

You need the credible route before the product story hardens.

Clarify intended purpose, claims, classification and evidence so the next commercial move is built on a defensible regulatory path.

Define the productTurn claims, users, intended purpose and risk into a route that can survive buyer and regulator scrutiny.
Map the market routeChoose the UK, EU, FDA or multi-market pathway before documentation work drifts in the wrong direction.
Build the evidence planPrioritise the technical, clinical, software and quality evidence that unlocks the next commercial move.

Shape market access

Featured thinking

Regulatory clarity for the products that cannot afford to wait.

Health-tech teams need evidence, quality systems and market decisions that move at the speed of product development.

Immersive bright light installation suggesting connected capability paths.

SaMD / AIaMDFirst-class regulatory capability without the corporate machine.For startups and scale-ups that need credible market access before they can justify a large internal compliance department.Read perspective

PerspectiveEU AI ActWhat the EU AI Act means for medical AIHow high-risk classification interacts with medical device regulation, and the governance founders should build before assessment pressure arrives.Read more

GuideNHSA practical guide to passing DTACThe five DTAC domains, the evidence assessors expect, and how to prepare without turning delivery into paperwork theatre.Read more

BriefingUS market510(k) vs De Novo: choosing your FDA pathwayHow to decide which route fits your device and how to avoid the detours that can cost a young company months.Read more

What we do

Compliance delivery for regulated software and AI health products.

Neural Vibe works where medical device regulation, AI governance, NHS assurance, quality systems and market access meet. The homepage highlights the main paths through that work; the services index carries the full catalogue.

Market access

Clarify the regulated route before the product story hardens.

Classification, intended purpose, claims and technical evidence shaped into a credible route to market.

SaMD / AIaMDSoftware and AI medical device market accessRoute-to-market strategy for SaMD and AIaMD products, including intended purpose, classification, claims, evidence planning and launch sequencing.

Device regulationMedical device compliance and technical evidenceUK MDR, EU MDR, technical documentation, clinical evaluation, post-market surveillance, UKCA and CE readiness.

AI and quality systems

Put governance and operating controls around fast-moving AI work.

Practical AI governance, ISO readiness and management-system foundations that support delivery rather than slowing it.

AI governanceAI regulation, risk management and ISO 42001EU AI Act readiness, AI risk management, human oversight, model governance, technical documentation and AI management systems.

Management systemsISO systems for regulated health technologyLean, audit-ready systems for ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001 and ISO 42001.

NHS adoption

Turn assurance, deployment and specialist support into one plan.

Buyer evidence, responsible AI implementation and specialist coordination for teams moving toward real-world adoption.

Healthcare AIHealthcare AI advisory and implementation supportAI readiness, governance, responsible adoption, assurance planning and deployment support for healthcare organisations, NHS teams and health tech developers.

NHS readinessNHS, DTAC, clinical safety and buyer evidenceDTAC, DCB 0129, DSPT, information governance, security, privacy evidence and adoption readiness for NHS and enterprise buyers.

OrchestrationSpecialist compliance network, managed for youNeural Vibe brings in trusted third-party specialists where a project needs deeper expertise and manages the work through one accountable plan.

View all services

Healthcare AI and NHS assurance

Healthcare AI and digital health assurance, without slowing the work.

Neural Vibe helps health tech companies and healthcare organisations make practical decisions about AI, data, safety, regulation and deployment. The work connects product strategy, clinical risk, information governance, technical assurance and market access into one accountable plan.

Doctor consulting with a patient at a desk.

AI advisoryResponsible AI adoption shaped around real health and care settings.Readiness assessments, AI assurance planning, evaluation support and implementation roadmaps for teams developing, selecting or deploying AI-enabled health technology.Explore AI advisory

Blue and purple light lines representing governed health data movement.

NHS information governanceData, DPIA, DSPT and confidentiality evidence that stands up.Information governance support for NHS-facing digital health and AI services, including data-flow review and controller or processor analysis.See IG support

Two colleagues reviewing data on a laptop during implementation planning.

Implementation assuranceDeployment readiness for real health and care environments.Stakeholder, training, operational readiness, interoperability and assurance checkpoints for suppliers and healthcare organisations.Review assurance

Market access pathway

From product uncertainty to regulated launch.

The work starts by defining what the product is, what the market will expect, and which evidence unlocks the next commercial move.

Explore the pathway

Define the regulated product

Clarify intended purpose, claims, users, clinical context, software boundaries and whether the product is SaMD, AIaMD or adjacent health technology.

Choose the route to market

Map UK, EU, US and international routes, identify assessment bodies, confirm evidence expectations and sequence work around funding and launch goals.

Build the evidence system

Create the technical, clinical, risk, software, security, AI governance and quality evidence that supports the chosen route.

Coordinate specialists

Bring in clinical, security, legal, notified body, FDA, international or implementation specialists where the project needs deeper support.

Sustain market access

Keep post-market surveillance, change control, security, model monitoring and renewals aligned as the product scales.

Built for startups and scale-ups

Serious regulatory capability. Lean enough for the teams changing healthcare.

Established manufacturers have departments, committees and mature systems. Earlier-stage health-tech companies still need first-class regulatory thinking - just delivered with sharper priorities, less overhead and a clearer route to market access.

How Neural Vibe works

Startups

Built for teams without a large internal regulatory department

Scale-ups

Structured for market expansion, audits and buyer scrutiny

Specialists

Trusted external experts coordinated under one plan

AI agents

Research, mapping and drafting accelerated under human review

One accountable partner

Founder-led, AI-enabled, specialist-backed.

Founder-led judgment

You work with one accountable lead who understands the product, the commercial pressure and the regulatory path.

AI-enabled delivery

Agent workflows accelerate research, mapping, drafting and checking, with human review kept firmly in control.

Specialists when needed

Clinical, security, legal, notified body, FDA and international experts are brought in only when the project benefits from deeper support.

Plain-English decisions

The output is not just documents. It is clarity on what matters now, what can wait and what will unblock market access.

Insights

Analysis for teams building regulated health technology.

Practical, plain-English thinking on the rules shaping SaMD, AIaMD, NHS readiness, ISO systems and global market access.

GuideQualityISO 13485 for software-only companiesHow to build a lean, audit-ready quality system when your product, evidence and release cycle are entirely software-led.Read more

PerspectiveClinical safetyDCB 0129 explained for manufacturersWhat clinical risk management involves, who needs a Clinical Safety Officer, and how to connect safety evidence to product decisions.Read more

ReportExpansionOne technical file, six marketsHow to structure claims, risk, software and clinical evidence so entering Canada, Australia and Brazil reuses what you have already built.Read more

BriefingAI assuranceISO 42001 as a trust signal for health AIWhy an AI management system can become more than certification work when buyers need proof of oversight and accountability.Read more

Start here

Let's map the fastest credible route to market.

Bring the product, the target markets and the questions. Neural Vibe will turn them into a practical compliance path.

Book a discovery call