Who this is for
- AI health-tech teams preparing for EU AI Act obligations.
- Companies using machine learning in clinical, operational or patient-facing workflows.
- Leadership teams that need governance before enterprise buyers ask for proof.
Services
AI governance
AI regulation, risk management and ISO 42001
EU AI Act readiness, AI risk management, human oversight, model governance, technical documentation and AI management systems.
EU AI ActISO 42001AI governance
Service detail
Show buyers, auditors and regulators that your AI is governed, monitored and clinically responsible.
Typical client problems
- The AI risk story is separate from the medical device risk story.
- Model monitoring, human oversight and change control are not defined.
- The team needs AI governance that is practical rather than decorative.
What Neural Vibe does
- Maps AI obligations against product claims, market route and clinical context.
- Builds a governance model for human oversight, monitoring, change control and documentation.
- Aligns ISO 42001, EU AI Act and medical device requirements where they overlap.
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
Obligation map
AI regulatory obligation map
A clear view of which AI rules, standards and buyer expectations apply to the product and why.
Buyer value
Helps leadership avoid both under-controlling AI risk and over-building governance that slows the product.
Neural Vibe does
We map intended use, market route, AI role, clinical context and user impact against EU AI Act, ISO and device obligations.
EU AI ActISO 42001Intended useClinical contextBuyer evidence
- 01Use case
- 02Rules
- 03Exposure
- 04Plan
Route
The pathway Neural Vibe manages.
Classify AI use and regulatory exposure.
Define governance and accountability.
Connect AI risk to clinical and product risk.
Prepare documentation for buyers and assessors.
Standards and regulations
Frameworks this work can cover.
EU AI ActISO 42001ISO 23894ISO 14971IEC 62304EU MDR
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