Description
Unlock the future of healthcare: Artificial Intelligence is transforming diagnostics, robotics, and personalized medicine-but innovation brings new risks. Join our exclusive seminar to discover cutting-edge strategies for navigating the unique challenges of risk management in AI-powered medical devices and IVDs. Ensure regulatory compliance, protect patients, and lead your organization confidently into the next era of medical device software technology.
By the end of this seminar, you will have gained an overview of the global requirements for risk management of AI-related medical devices and IVDs. You will also develop practical skills in risk assessment and mitigation, ensuring compliance and successful market access for AI-powered health technologies.
SEMINAR CONTENT
Risk Management for AI-based Medical Devices and IVD
- Risk management basics, definitions of terms
- Risk classification according to EU AI Act and MDR/IVDR
- Relevant standards:
- ISO 14971 (general risk management),
- AAMI/BSI TR 34971 (AI-specific risks),
- IEC 62304 (Risk management in the software life cycle)
- Special requirements and challenges:
- Data management: selection, anonymization, quality and representativeness of training data, validation and verification of AI models (e.g. robustness, generalizability),
- Dealing with adaptive and learning systems (continuous learning),
- Human oversight: mechanisms for human control and intervention options
- Exercise:
- Create a risk matrix for an AI diagnostic tool: Participants analyze a fictitious AI-based diagnostic system, identify possible risks (e.g. incorrect classification, data bias) and evaluate these together in a risk matrix.
Date
18.11.2025, 13:30 – 17:30
PARTICIPANTS
Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485
This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.
YOUR TRAINER
- Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG
COSTS
- Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
- Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
- incl. seminar documentation as PDF and certificate of participation
- All seminar discounts at a glance
EVENT LOCATION: ONLINE
You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.
