AI Act, MDR/IVDR, QMSR: Practical AI compliance trainings for medical devices
We design on-demand trainings for your roles, maturity level, and objectives — from executive briefings to hands-on workshops. We combine regulatory interpretation and best practice with implementation guidance, grounded in real-world medical device development.
What we offer
Our AI trainings help medical device organizations understand what “good” looks like for AI across the lifecycle — aligned with regulatory expectations and the realities of engineering, data, and product delivery. Each training is custom-built: we clarify your actual goal, identify risks and pain points, and tailor content to your audience — from technical teams to cross-functional stakeholders.
Problems we help you solve
Many organizations face similar questions once AI concepts meet regulatory reality:
- “Do we have enough data?” — considering intended use, performance, bias, and lifecycle management
- Evidence beyond performance — traceability, provenance, and controlled development
- Limits of adaptive learning — safety, stability, and change control implications
- Supplier control for data providers and governance within quality systems
- Aligning AI Act, MDR/IVDR, and QMSR requirements
- Adapting to evolving expectations beyond past audit success
These challenges often highlight gaps between AI development practices and regulatory expectations.
Topics we cover
A. Regulatory landscape & interpretation
- EU AI Act and its relationship with MDR/IVDR
- FDA direction for AI/ML-enabled devices
- IMDRF alignment
B. AI lifecycle expectations
- Intended purpose, claims, and clinical relevance
- Data governance: provenance, bias, representativeness
- Development evidence beyond metrics
- AI-specific risk management approaches
- Post-market monitoring and performance drift
C. Quality system integration
- Integrating AI into QMS processes
- Supplier and data governance
- Practical and defensible documentation strategies
D. Standards and references
- IEC PAS 63621:2026
- ISO/TS 24971-2
- Context and applicability of IEC 62304 and IEC 82304-1
Standards are referenced where useful, not as certification targets. Trainings are always tailored to your product, context, and audience.
How it works
- Scoping call (30–60 minutes) to align on goals and key questions
- Tailored agenda based on your maturity and context
- Training delivery (remote, onsite, or hybrid)
- Optional follow-up with Q&A or next steps
Format examples
- Executive briefings (60–120 minutes)
- Half-day or full-day workshops
- Multi-session programs
- Cross-functional alignment sessions
- Project-adjacent enablement training
What defines our approach
Our AI trainings draw on extensive experience at the intersection of regulation and real-world AI development. We combine regulatory expertise with hands-on technical understanding, ensuring content is both accurate and practical. The focus is on solutions that are defensible, auditable, and sustainable as regulatory expectations evolve.
Get started
Interested in a tailored AI training? Start with a short scoping conversation to align on your goals, audience, and key challenges.
Learning Outcomes
Who it’s for
These trainings are relevant for different roles for different reasons — from strategic decision‑making to hands‑on implementation and evidence generation. They are especially valuable where a shared understanding across disciplines is required.
- Executive and leadership teams who need decision clarity on feasibility, risk, and investment priorities
- Product & program owners who translate AI ideas into deliverable plans and evidence
- Regulatory affairs & clinical teams responsible for claims, intended purpose, and regulatory strategy
- Quality & process owners who must operationalize controls, documentation, and supplier governance
- Software/AI engineering & data science teams who build models and need clarity on “what regulators actually expect”
- Cross-functional groups where alignment is the main blocker (and misunderstandings are expensive)
Explore related topics
510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
CAPA Considerations: A Comprehensive Overview
Change Management in Practice - Selected Practical Examples for Evaluating Changes
China Registration - Approval for Medical Devices in China
Need help choosing?
Our training advisors can help you find the perfect match.