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

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

Who should Attend

Regulatory / Compliance Managers and Specialists, Project Managers, System Engineering, Quality Assurance Managers, Software Engineers and Hardware Engineers.