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AI

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.

Duration
16h · 2 days
Who it's for

Ideal for teams that…

1 AI/ML developers and engineers in the healthcare sector
2 AI system architects
3 Compliance and regulatory specialists
4 Product owners responsible for developing AI-based medical systems
5 QA/Validation teams in MedTech companies
Outcomes after the program

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

Requirements

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
Program · 9 modules

What we actually do

M01
Introduction to the AI Act
  • · Structure and objectives of the AI Act
  • · Types of AI systems and their classification
  • · Relationship between the AI Act, MDR, GDPR, and ISO standards
M02
Risk Classification and Manufacturer Obligations
  • · High-risk vs. other AI systems
  • · Requirements for “high-risk AI” systems
  • · Roles of provider, user, importer, and distributor
M03
Securing AI Models in Healthcare
  • · Protection against errors and adversarial attacks
  • · Data source verification and model version control
  • · Transparent vs. black-box models (in the context of explainability obligations)
M04
AI Technical Documentation
  • · Documentation requirements under the AI Act
  • · How to prepare: model cards, data sheets, algorithm impact assessments
  • · Step-by-step creation of Technical Documentation
M05
Workshop: Classification & Evaluation of AI Systems
  • · Hands-on case studies (e.g., ECG evaluation model, medical triage chatbot)
  • · Defining risk level, documentation requirements, and conformity assessment process
M06
Conformity Assessment and Audits
  • · Overview of notification procedures
  • · Self-assessment vs. third-party assessment
  • · Role of the notified body and declaration of conformity
M07
Validation and Testing of AI Models in Medical Environments
  • · Pre-clinical and clinical testing
  • · Model metric validation vs. clinical validation
  • · Test cases, validation plans, traceability matrices
M08
Post-deployment Monitoring and Oversight Systems
  • · Logging, alerts, and error handling
  • · Documenting corrective actions and updates
  • · Retraining and lifecycle management
M09
Ethics and Accountability under the AI Act
  • · Transparency, human oversight, interpretability
  • · Implementing “human-in-the-loop” principles
  • · Examples of violations and legal consequences
Every module is adapted to your stack and context. The above is a starting point — not a fixed agenda.
How we work

From brief to retro in 30 days.

01

Brief & diagnosis

A call with the team lead + a short survey for participants. We define goals, gap and context.

02

Program customization

We adapt modules, case studies and code examples to your stack. Approval in 5 days.

03

Workshop

Trainer-led sessions, hands-on, code review. Mentor available between sessions too.

04

Retro + report

Outcome report for the team and lead. 30 days of consulting included.

Inquiry

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.

Quote within 48h of the brief
First session within 30 days
Pilot before the full decision
VAT invoice, payment in instalments possible

How we handle your data

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