Services
From AI readiness and NHS digital health assurance to medical device evidence and multi-market expansion, Neural Vibe supports suppliers and healthcare organisations through one accountable advisory model.
We buildroute-to-market clarity
Choose your route
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
Capability index
Strategy, technical evidence, management systems and specialist workstreams connected into one delivery model.
Market access and medical device regulation
Preserve the route-to-market story: product classification, technical evidence, quality controls, UK MDR, EU MDR, FDA and international expansion.
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.SaMDAIaMDMarket accessSee how we help 
Device regulationMedical device compliance and technical evidenceUK MDR, EU MDR, technical documentation, clinical evaluation, post-market surveillance, UKCA and CE readiness.UK MDREU MDRUKCA / CESee how we help 
InternationalFDA and multi-market submissions510(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 NovoANVISASee how we help Healthcare AI and NHS assurance
AI readiness, governance, DTAC, clinical safety, NHS information governance and assurance planning for suppliers and healthcare organisations.
AI governanceAI regulation, risk management and ISO 42001EU AI Act readiness, AI risk management, human oversight, model governance, technical documentation and AI management systems.EU AI ActISO 42001AI governanceSee how we help 
AI deploymentAI Governance Toolkit for health technologyPractical AI governance for developers building AI-enabled health products and NHS organisations deploying AI safely at speed and at scale.AI safetyNHS deploymentGovernanceSee how we help 
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.AI readinessImplementationAssuranceSee how we help 
NHS readinessNHS, DTAC, clinical safety and buyer evidenceDTAC, DCB 0129, DSPT, information governance, security, privacy evidence and adoption readiness for NHS and enterprise buyers.DTACDCB 0129NHS assuranceSee how we help 
DTAC readinessDTAC Gap Analysis and Readiness PlanA focused assessment of your current DTAC readiness, the gaps that could block NHS adoption, and the plan to close them.DTACGap analysisNHS readinessSee how we help 
Information governanceNHS digital health information governance and assuranceDSPT evidence, DPIAs, data sharing, controller analysis, Caldicott considerations and information governance support for NHS-facing digital health and AI services.DSPTDPIANHS IGSee how we help Implementation, security and operational readiness
Quality systems, cybersecurity, supplier coordination and specialist support connected to adoption, assurance and long-term market access.
Management systemsISO systems for regulated health technologyLean, audit-ready systems for ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001 and ISO 42001.ISO 13485ISO 27001ISO 42001See how we help 
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.One partnerSpecialist networkDeliverySee how we help SaMD and AIaMD first
Claims, intended purpose, users, clinical context, model behaviour and software boundaries shape everything that follows. Neural Vibe starts there, then builds the evidence system around the route.
Discuss your productClarify intended purpose, claims, users, clinical context, software boundaries and whether the product is SaMD, AIaMD or adjacent health technology.
Map UK, EU, US and international routes, identify assessment bodies, confirm evidence expectations and sequence work around funding and launch goals.
Create the technical, clinical, risk, software, security, AI governance and quality evidence that supports the chosen route.
Bring in clinical, security, legal, notified body, FDA, international or implementation specialists where the project needs deeper support.
Keep post-market surveillance, change control, security, model monitoring and renewals aligned as the product scales.
Markets
United Kingdom
European Union
United States
International
ISO and assurance
Neural Vibe designs, implements, embeds and maintains the management systems that regulated health technology companies need to win trust, pass audits, satisfy buyers and keep improving after certification.
Define scope, objectives, process architecture, policies, controls, roles, registers and the evidence model around how the client actually works.
Turn the system into day-to-day routines: risk review, supplier review, change control, document control, incident handling, competence, objectives and operational evidence.
Run readiness reviews, close gaps, prepare audit evidence, brief the team and sit with the client through Stage 1, Stage 2 or external assessment activity.
Represent the client during certification and surveillance visits, then support internal audits, management reviews, supplier reviews, risk reviews and continual improvement.
Information security management that gives NHS, enterprise and public sector buyers confidence in how you protect data, operate services and control suppliers.
Build security assurancePrivacy information management that extends security governance into GDPR accountability, DPIAs, processor control and buyer-ready data protection evidence.
Strengthen privacy governanceQuality management foundations for repeatable service delivery, controlled processes, corrective action, measurable improvement and customer confidence.
Create a quality backboneMedical device quality management for software and AI health products, connecting design control, supplier control, CAPA, post-market evidence and regulatory readiness.
Make QMS work for softwareAI management systems for accountable, monitored and governed AI, aligned with product risk, human oversight, model change and health-sector adoption evidence.
Govern AI with confidenceEnvironmental management systems for objectives, aspects, supplier engagement, evidence of improvement and credible sustainability governance.
Operationalise sustainability
AI governanceHelp the NHS implement AI safely, at speed and at scale.A practical governance toolkit for developers building AI-enabled health tech and NHS organisations deploying it responsibly.See toolkit 
DTAC readinessFind the gaps before NHS buyers find them for you.A focused DTAC gap analysis with a practical plan to close clinical safety, IG, security, usability and accessibility gaps.Start gap analysis 
Specialist networkThe right expert at the right moment, managed through one plan.Neural Vibe brings in deeper expertise when needed and keeps the client relationship accountable.See network Start here
That is the most common place to start. We will map the product, the market and the evidence path before you spend months in the wrong workstream.
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