Applying ISO14971 and IEC62304 - A guide to practical Risk Management


Applying ISO14971 and IEC62304 - A guide to practical Risk Management is a seminar that covers topics such as:

  • 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

Applying ISO14971 and IEC62304 - A guide to practical Risk Management is intended for:

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

Future Events

Past Events


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions