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.
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.
AI regulatory obligation map
AI risk and governance framework
Human oversight model
Model monitoring and change control plan
ISO 42001 readiness roadmap
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