intellcert Academy · Artificial Intelligence
EU AI Act & AI in Medical Devices (SaMD): Implementation, Validation & Risk Management
This course conveys the regulatory, technical and organizational requirements for the use of AI systems in medical devices and safe
Overview
Course contents
Our professional training courses are designed for professionals, specialists, and experts who wish to expand their knowledge in a targeted way.
Hands-on exercises
- 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
Learning objectives
- Classifying and applying the EU AI Act in the context of medical devices
- Classifying AI-based software as a medical device
- Combining regulatory requirements from MDR/IVDR and the AI Act
- Explaining and implementing requirements for the clinical validation of AI systems
- Systematically evaluating risks of AI in the medical context
- Considering requirements for data quality, bias and robustness in the healthcare context
- Structuring documentation and evidence obligations for AI medical devices
- Understanding the particularities of learning AI systems in regulated environments
Target audience
- Regulatory Affairs Managers in MedTech companies
- Quality management (QA/RA)
- Medical device software developers
- AI developers in healthcare
- Clinical Affairs / Clinical Evaluation teams
- Manufacturers of Software as a Medical Device (SaMD)
- Auditors and external assessors in the MedTech sector
- Participants from IC-805-E-08 with a healthcare industry focus
Prerequisites
- Required:
- Comparable basic knowledge of AI systems and their applications
- Strongly recommended:
- Basic understanding of quality and regulatory systems (e.g., ISO 13485 or MDR fundamentals)
- Optional (for technical participants):
Required
- IC-805-E-01. Understanding and Safely Applying AI, or
- IC-805-E-08. Regulated AI, Safety & Governance
- IC-805-E-04. Developing and Integrating AI Systems
Certification requirement
Without certification option
Delivery format: Online. For on-site or in-house training, please send us a request via our contact form. We will get in touch with you shortly thereafter.
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