Training Features

EU 2024 1689 AI Act for Medical Devices: Essential Principles and How to Put Them into Practice

This virtual training equips medical device and IVD professionals with the essential knowledge and practical steps needed to ensure their AI-driven products comply with the stringent requirements of the EU Artificial Intelligence Act (AI Act) 2024/1689.
Format

Virtual Training

Level

Basic

Date

16 and 22 July 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Coenraad Davidsdochter

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Master the EU AI Act for Medical Devices: Essential Principles and Practical Compliance

The EU Artificial Intelligence Act (AI Act) 2024/1689 introduces a landmark regulatory framework, profoundly impacting the development, placement, and use of AI systems within the medical device and in vitro diagnostic (IVD) sectors. Given that many AI applications in healthcare are classified as high-risk, understanding and implementing this new regulation is critical for continued market access in the EU.

Led by Coenraad Davidsdochter, this interactive training is designed to bridge the gap between the theoretical requirements of the AI Act and the practical reality of bringing a medical device to market.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The EU Artificial Intelligence Act (AI Act) 2024/1689 introduces a comprehensive regulatory framework for AI systems, including those used in medical devices and in vitro diagnostics (IVDs). Whether this is as a stand-alone AI application or part of an (in vitro) medical device. This regulation sets requirements for high-risk AI applications, ensuring safety, transparency, and compliance with ethical principles. 

Qserve organizes training to help medical device and IVD professionals understand the AI Act’s key requirements and practical implications. This course covers classification, conformity assessment, risk management, and integration with the MDR/IVDR. Participants will receive a certificate upon completion, confirming their understanding of the AI Act’s application in the medical sector. 
Key Learning Objectives
  • Understand the purpose and scope of the EU AI Act and its relation to MDR/IVDR.
  • Learn how AI-based medical devices are classified and regulated under the AI Act.
  • Gain insights into the required conformity assessment and compliance steps.
  • Understand AI risk management requirements, including bias prevention and transparency. 
  • Learn how to develop technical documentation for AI-based (in-vitro) medical devices.
  • Explore how to integrate AI regulatory compliance into an existing QMS.
  • Gain knowledge on post-market surveillance and monitoring obligations for AI systems.
  • Identify key challenges and best practices for implementing AI Act requirements in the medical sector.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 16 and 22 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the July training date is not suitable, additional sessions will be held on 12 and 18 February, 14 and 20 April, and 13 and 19 October 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals working with AI-driven (in-vitro) medical devices.
  • Quality Assurance managers and directors responsible for AI compliance.
  • Manufacturers, authorized representatives, importers, and distributors of AI-based (in-vitro) medical devices.
  • R&D and software engineers developing AI models for (in-vitro) medical applications.
  • Post-market surveillance (PMS) and vigilance specialists dealing with AI performance monitoring.
  • Anyone seeking a fundamental understanding of the AI Act and its impact on medical devices and IVDs. 
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework & Background. Overview of the AI Act and its relation to MDR/IVDR, AI risk classification and scope of the regulation, and Key principles.  
  • Classification & Conformity Assessment. Defining high-risk AI systems in medical device, Conformity assessment routes and Notified Body involvement, and Required documentation for AI-based medical devices.
  • AI Risk Management & Technical Documentation. Risk management obligations under the AI Act, Data quality, bias prevention, and explainability requirements, and Technical documentation and lifecycle monitoring.
  • Quality Management System (QMS) & Compliance. Integrating AI compliance within an existing QMS (ISO 13485), Post-market monitoring and reporting obligations, and Incident reporting and corrective actions.
  • Post-Market Surveillance (PMS) & Real-World Performance. Continuous monitoring and updating of AI models, Handling real-world data and drift detection, and Alignment with MDR/IVDR post-market requirements. 
  • Practical Implementation & Industry Impact. Steps for aligning AI-based devices with the AI Act, Challenges and best practices for manufacturers of (in-vitro) medical devices, and Future regulatory developments and AI governance trends.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Coenraad Davidsdochter

Coenraad Davidsdochter, a Senior Consultant in Software and Artificial Intelligence, brings over 20 years of software development experience and more than a decade in establishing and managing Quality Management Systems (QMS) compliant with ISO 13485, MDD 93/42/EEC, MDR 2017/745, and GDPR 2016/679, and has extensive expertise in areas such as technical file documentation, risk management, clinical evaluations, and information security.