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MD QMS Assure · Quality & regulatory
AI governance for medical devices
If your device uses AI, the EU AI Act adds a second set of high-risk obligations on top of the MDR. We map what applies to your product, what your existing evidence already covers, and what is left to build.
Why it matters
Following the AI Digital Omnibus, which entered into force on 27 July 2026, high-risk obligations for AI in products covered by EU sectoral legislation (including medical devices) apply from 2 August 2028.
Much of what the AI Act asks for (risk management, data governance, technical documentation, post-market monitoring) overlaps with MDR evidence. Planning the two together avoids building the same file twice.
Who it’s for
- AI-enabled diagnostic, imaging and decision-support software
- Device companies whose customers ask for ISO 42001 or AI governance evidence
What’s included
- Classification: whether and how the AI Act applies to your device
- Obligations map from now to 2 August 2028
- Gap analysis against ISO/IEC 42001 (AI management systems) and your existing MDR documentation
- Readiness roadmap sequenced with your certification and product plans
Deliverable
Obligations map and readiness roadmap.
Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.
How it works
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Questions we’re often asked
Is ISO 42001 required by the AI Act?
No. ISO/IEC 42001 is a voluntary management-system standard. It is a practical way to organise AI governance evidence, and some customers and partners ask for it, but it is not itself an AI Act requirement.
The deadline is 2028. Why start now?
Because the evidence builds up over product releases. Starting early lets you design it into your development process instead of reconstructing it before a conformity assessment.
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Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.