Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance 2012

  • 04-05 Oct 2012
  • Courtyard San Diego Downtown, CA, United States

Description

Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance is a conference dedicated to compliance issues relating to ISO14971, IEC62304 and IEC60601-1:2005., including:

  • IEC60601-1:2005 (medical device basic safety  and essential performance)
    • Section 4 Risk Related Issues
    • References to Risk Management
    • The IEC TRF (technical report form)
    • Compliance for Non-Software Related Issues
    • PEMS and IEC62304
    • Special PEMS Issues
  • ISO 14971 (the requirements for a risk management system for medical devices)
    • Risk Management Life Cycle
    • Risk Management Planning
    • Hazard Domains
    • Hazard Identification
    • Risk Rating Methods
    • Hazard Latency Issues
    • Mitigation Strategies and Priorities
    • Initial (unmitigated) Risk Assessment
    • Alarm Systems as Mitigations
    • Mitigation Architectures
    • Post Mitigation Risk
    • Risk Control Bundles
    • Safety Integrity Levels
    • Residual Risk
    • Safety Requirements
    • Usability as Hazard Source and Mitigation
    • Verification Planning
    • Hazard Mitigation Traceability
    • Failure Mode and Effect Analysis / FTA
    • Architectures, Redundancy and Diversity
    • System Validation / Mitigation Validation
    • Verification Strategies
  • IEC62304 (medical device software)
    • 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

Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance brings together Regulatory / Compliance Managers and Specialists, Project Managers, System Engineering, Quality Assurance Managers, Software Engineers and Hardware Engineers.

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Important

Please, check "Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Risk Management
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device

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