Agenda and Content

• Recap - Introduction for Functional Safety
• Regulatory Basics and Legal Aspects for Medical Devices
  • Standards, Regulations and their Interactions, such as:
  • Device and Safety Classification
• Essential Performance and Basic Safety
• Single Fault Safe Systems - Single Fault Conditions
• Creating a safety argument based on key techniques to handle Functional Safety in Medical Devices
  • Risk Management Lifecycle
  • Architecture, Design and Safety Design Patterns
  • Verification and Validation
  • Safety Analyses
• Impact of Artificial Intelligence and Machine Learning to Functional Safety

Who should attend?

Safety engineers, who want to learn more about safety related medical device development, such as:

• Safety Managers and Project Managers
• Development and Safety Engineers (System, HW and SW)

Basic experience in functional safety is beneficial.