Expertise
Specialist capability,coordinated through oneaccountable partner.
Neural Vibe is founder-led and AI-enabled, with specialist capability across medical device regulation, healthcare AI, NHS assurance, information governance, interoperability and international market access.
Coordinateregulatory strategy
Subject-matter network
Expertise without making the client manage the expert bench.
These are capability areas, not fake biographies. When a project needs deeper support, Neural Vibe coordinates the right specialist input through one route-to-market, assurance or deployment plan.
Regulatory and market access
Shape the product, claims and evidence route.
ExpertiseSaMD regulatory strategyClassification, intended purpose, claims, evidence planning and route-to-market strategy for software-first medical products.Explore expertise >
ExpertiseQuality and ISO systemsLean, audit-ready management systems for ISO 13485, ISO 14971, IEC 62304, ISO 27001 and ISO 42001.Explore expertise >
ExpertiseFDA and international submissionsPathway planning, evidence reuse and specialist coordination for FDA, Canada, Australia, Brazil and multi-market expansion.Explore expertise >NHS and clinical assurance
Prepare for adoption in real health and care settings.
ExpertiseClinical safety and DCB 0129Clinical risk management, safety evidence and DCB 0129 readiness for digital health products used in care settings.Explore expertise >
ExpertiseNHS assurance and DTACBuyer-ready evidence for DTAC, information governance, security, accessibility, clinical safety and NHS adoption conversations.Explore expertise >
ExpertiseInteroperability and technical assuranceHigh-level architecture, data-flow, API, interoperability, cloud, security and supplier technology assurance for healthcare AI and digital health services.Explore expertise >AI, security and information governance
Connect responsible AI with privacy, security and oversight.
ExpertiseAI governance and EU AI ActAI risk, human oversight, model monitoring, ISO 42001 and EU AI Act readiness for health technology teams.Explore expertise >
ExpertiseCybersecurity, privacy and information governanceSecurity, privacy and information governance evidence for healthcare buyers, ISO systems and regulated software products.Explore expertise >Start here
Need more than one specialist?
That is exactly where orchestration matters. Neural Vibe keeps the specialist work connected to one accountable route-to-market plan.
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