Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019

  • 03-04 Oct 2019
  • Philadelphia, PA, United States

Description

Topics
  • IEC62304 (International standard for medical device software)
    • Software Verification and Validation
    • Critical Software Issues
    • Software Hazard Mitigation Strategies
    • Software Item, Unit and System Definition
    • Software Tools and Development Environment
    • Real-Time System Challenges
    • Software Requirements and Design Specification
    • Software Failures as Hazard Sources
    • Mitigation Traceability and Effectiveness
    • Software Unit and Integration Testing
  • IEC60601-1:2005 (Technical standards for the safety and effectiveness of medical electrical equipment)
    • Section 4 Risk Related Issues
    • References to Risk Management
    • Special PEMS Issues
    • The IEC TRF (technical report form)
    • Compliance for Non-Software Related Issues
    • PEMS and IEC62304
  • ISO 14971 (Requirements for a risk management system for medical devices)
    • Verification Strategies
    • Post Mitigation Risk
    • Architectures, Redundancy and Diversity
    • Hazard Mitigation Traceability
    • Residual Risk
    • Failure Mode and Effect Analysis / FTA
    • Alarm Systems as Mitigations
    • Usability as Hazard Source and Mitigation
    • Risk Management Life Cycle
    • Safety Integrity Levels
    • Initial (unmitigated) Risk Assessment
    • Hazard Latency Issues
    • Mitigation Strategies and Priorities
    • System Validation / Mitigation Validation
    • Safety Requirements
    • Mitigation Architectures
    • Risk Rating Methods
    • Hazard Identification
    • Risk Management Planning
    • Hazard Domains
    • Verification Planning
    • Risk Control Bundles
Who should Attend
  • Project Managers
  • Quality Assurance Managers
  • Software Engineers
  • Regulatory / Compliance Managers and Specialists
  • Hardware Engineers
  • System Engineering

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Please, check "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance

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