AI in Medicine and the AI Act – Safe AI Systems in Healthcare
Hands-on AI and data analytics workshops — built around your team's real cases.
Ideal for teams that…
Hands-on AI and data analytics workshops — built around your team's real cases.
AI Act classification of systems – Understand whether your system is “high-risk,” “general purpose,” or “prohibited”
Model safeguards and oversight – Learn how to design AI models resilient to errors, manipulation, and data breaches
Conformity assessment and technical documentation – Master the structure of Technical Documentation and how to build it step by step
Monitoring and continuous improvement – Learn to implement logging, error handling, validation, and retraining processes in line with the AI Act
What you should know before we start
- Good understanding of AI and ML fundamentals
- Practical knowledge of Python or another ML programming language
- General awareness of MDR and GDPR regulations
What we actually do
- · Structure and objectives of the AI Act
- · Types of AI systems and their classification
- · Relationship between the AI Act, MDR, GDPR, and ISO standards
- · High-risk vs. other AI systems
- · Requirements for “high-risk AI” systems
- · Roles of provider, user, importer, and distributor
- · Protection against errors and adversarial attacks
- · Data source verification and model version control
- · Transparent vs. black-box models (in the context of explainability obligations)
- · Documentation requirements under the AI Act
- · How to prepare: model cards, data sheets, algorithm impact assessments
- · Step-by-step creation of Technical Documentation
- · Hands-on case studies (e.g., ECG evaluation model, medical triage chatbot)
- · Defining risk level, documentation requirements, and conformity assessment process
- · Overview of notification procedures
- · Self-assessment vs. third-party assessment
- · Role of the notified body and declaration of conformity
- · Pre-clinical and clinical testing
- · Model metric validation vs. clinical validation
- · Test cases, validation plans, traceability matrices
- · Logging, alerts, and error handling
- · Documenting corrective actions and updates
- · Retraining and lifecycle management
- · Transparency, human oversight, interpretability
- · Implementing “human-in-the-loop” principles
- · Examples of violations and legal consequences
From brief to retro in 30 days.
Brief & diagnosis
A call with the team lead + a short survey for participants. We define goals, gap and context.
Program customization
We adapt modules, case studies and code examples to your stack. Approval in 5 days.
Workshop
Trainer-led sessions, hands-on, code review. Mentor available between sessions too.
Retro + report
Outcome report for the team and lead. 30 days of consulting included.
Send a brief. We'll reply within 1 day.
After a short brief we'll prepare a program and a quote. No obligations — it's just a starting point.
Thank you!
We'll get back to you within 1 business day.
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