EU AI Act and AI in Medical Devices (SaMD): Implementation, Validation and Risk Management

Description

• Course ID:
  • IC-805-E-09
• Content: This course covers the regulatory, technical, and organizational requirements for the use of AI systems in medical devices and safety-critical healthcare applications. The focus is on the practical implementation of the EU AI Act in combination with medical device regulations (MDR/IVDR), as well as the validation of AI systems as Software as a Medical Device (SaMD).
  • Key Topics:
    • Overview of the EU AI Act with a focus on high-risk AI systems in healthcare
    • Interaction between the EU AI Act, MDR (Medical Device Regulation), and IVDR
    • Classification of AI systems as medical devices (SaMD)
    • Requirements for clinical evaluation and clinical evidence
    • Risk management according to ISO 14971 in the context of AI systems
    • Validation and verification of AI models in medical environments
    • Requirements for data quality, data representativeness, and bias in healthcare applications
    • Post-market surveillance for AI-based medical devices
    • Documentation requirements (technical documentation, clinical evaluation reports)
    • Lifecycle management of AI in regulated medical systems
    • Change management for learning or adaptive AI systems
    • Auditability and traceability towards notified bodies
    • Requirements for explainability and transparency in clinical AI systems
  • Practical Components:
    • Evaluation of an AI use case regarding SaMD suitability
    • Conducting a simplified AI risk analysis in a medtech context
    • Creating a structured documentation outline (e.g., risk file / clinical summary)
    • Analysis of common failure sources in medical AI applications
    • Case studies from diagnostic and assistive AI systems
• Prerequisites:
  • Required:
    • IC-805-G-01 – Understanding and Safely Applying AI, or
    • Comparable basic knowledge of AI systems and their applications
  • Strongly recommended:
    • IC-805-G-08 – Regulated AI, Safety & Governance
    • Basic understanding of quality and regulatory systems (e.g., ISO 13485 or MDR fundamentals)
  • Optional (for technical participants):
    • IC-805-G-04 – Developing and Integrating AI Systems
• Certification Requirement:
  • Without certification option
• Conduction Method:
  • Online (For on-site or in-house training, please send us a request via our contact form (Contact - intellcert). We will get in touch with you shortly thereafter.)
• Language:
  • English
• Target  Audience:
  • Regulatory affairs managers in medtech companies
  • Quality assurance (QA/RA) professionals
  • Medical device software developers
  • AI developers in healthcare
  • Clinical affairs / clinical evaluation teams
  • Manufacturers of Software as a Medical Device (SaMD)
  • Auditors and external reviewers in the medtech sector
  • Participants of IC-805-G-08 with a healthcare industry focus
• Learning Objectives:
  • Participants will be able to:
    • Interpret and apply the EU AI Act in the context of medical devices
    • Classify AI-based software as a medical device
    • Combine regulatory requirements from MDR/IVDR and the AI Act
    • Explain and implement requirements for clinical validation of AI systems
    • Systematically assess risks of AI in medical contexts
    • Consider requirements for data quality, bias, and robustness in healthcare applications
    • Structure documentation and traceability requirements for AI medical devices
    • Understand the specific challenges of learning AI systems in regulated environments
• Note:
  • Displayed price excl. VAT