Medical Device Software Risk Management and Assurance Case 2014

  • 19-20 Jun 2014
  • Courtyard Boston Logan Airport, MA, United States

Description

Medical Device Software Risk Management and Assurance Case 2014 is a seminar that covers topics such as:

  • Risk Management to ISO 14971:2012
    • Risk Management Life Cycle
    • Risk Management Planning
    • Initial (unmitigated) Risk Assessment
    • Hazard Identification
    • Mitigation Architectures
    • Mitigation Strategies and Priorities
    • Residual Risk - Safety Integrity Levels
    • Post Mitigation Risk
    • Safety Requirements
    • European special requirements (Z-Annexes)
    • Verification Planning
    • Hazard Mitigation Traceability
    • Failure Mode and Effect Analysis
    • Architectures, Redundancy and Diversity
  • Introduction into Risk Management and Quality System Integration
    • Risk Management Lifecycle and stakeholders
    • Why risk management?
    • How to Implement Risk Management into ISO13485
    • Risk Management Benefits
  • Safety / Assurance case
    • Documentation of Basic Safety
    • Safety classes
    • External safety
    • Documentation of essential performance
    • Assurance case vs. Risk Management Report
    • Verification of safety properties
  • Software Risk Management (IEC62304 / FDA software reviewers` guidance)
    • Software Hazard Mitigation Strategies
    • Critical Software Issues
    • Software Failures as Hazard Sources
    • Software Item, Unit and System Definition
    • Software Tools and Development Environment
    • Software Requirements and Design Specification
    • Real-Time System Challenges
    • Software Unit and Integration Testing
    • Mitigation Traceability and Effectiveness
    • Software Verification and Validation
    • Software Risk Management Process integration into ISO14971
    • Software Maintenance and Configuration Control
    • FDA documentation requirements
    • Legacy Software issues
    • Upcoming changes in IEC62304:2014

Medical Device Software Risk Management and Assurance Case 2014 brings together:

  • Quality Professionals
  • Senior Quality Managers
  • Compliance Professionals
  • Regulatory Professionals
  • Design Engineers
  • Project Managers
  • Process Owners
  • Software Engineers
  • Quality Auditors
  • Quality Engineers
  • Legal Professionals
  • Medical Affairs

Past Events

Important

Please, check "Medical Device Software Risk Management and Assurance Case" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Risk Management
Health & Medicine: Medical device
Technology: Software & Applications

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