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Functional Safety for Medical Device Development

Who should attend

  • Safety Managers
  • Development Engineers (System, Hardware and Software)
  • Product Managers
  • Project Leaders of safety related development projects
  • Process Managers
  • Quality Managers

Duration: 2 days

Language: German or English, training material will be in English.


View file
nameDE0401-Functional Safety for Medical Device Development.pdf

Scheduled courses - Register here:

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Course topics:

  • Introduction to Functional Safety
    • Regulatory Basics and Legal Aspects
    • Distinction between Functional Safety and Electrical Safety
    • Interaction of Standards and Regulations, such as:
      • IEC 61508
      • IEC 62304
      • Medical Device Regulation (MDR)
      • FDA Regulations
      • ISO 14971
      • IEC 60601
  • Impact of Faults to Systems
  • Fundamental Concepts
    • Development Lifecycle Models
    • Hazard and Risk Analysis and Risk Management
    • (Device) Classification in accordance to MDR, Safety Integrity Levels (IEC 61508), Software Safety Classification (IEC 62304), FDA Level of Concerns
    • Safety related Requirements
  • Key Techniques to handle Functional Safety on System, HW and SW Level
    • Architecture and Design Patterns
    • Requirements Engineering
    • Safety Analysis Methods, such as FME(D)A, FTA, DFA
    • Verification and Validation techniques
  • Model Based Development
  • Impact of Development and Test Tools on Functional Safety
  • Supporting Processes
    • Change Management
    • Configuration Management
  • Workshop: Guided development of selected tasks for an example project

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