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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.

Location: exida.com GmbH office

Prof.-Messerschmitt-Straße 1
D-85579 Neubiberg / Germany

or ONLINE

Brochure

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nameDE0401-Functional Safety for Medical Device Development_new.pdf
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Scheduled courses - Register here:

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Course topics:

  • Introduction to Functional Safety
    • Regulatory Basics and Legal Aspects
    • Interaction of Standards and Regulations, such as:
      • IEC 61508
      • ISO 14971
      • IEC 60601
      • IEC 62304
      • Medical Device Regulation (MDR)
      • FDA Regulations and Guidelines
    • Device and Safety Classification
  • Impact of Faults to Systems
  • Single Fault Conditions
  • Key Techniques to handle Functional Safety
    • Safety Management
    • Requirements Engineering
    • Architecture and Design
    • HW-SW-Interface
    • Verification and Validation Techniques
    • Safety Analyses
  • Supporting Processes
  • Workshop: Guided development of selected tasks for an example project


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