2-Day Course: Applying ISO14971 & IEC62304 – A Guide to Practical Risk Management (Philadelphia, United States – June 27-28, 2019) – ResearchAndMarkets.com


ISO14971 and IEC62304 – A guide to practical Risk Management”

conference has been added to ResearchAndMarkets.com’s

Gaps, incorrect or incomplete implementation of safety functionality can
delay or make the certification/approval of medical products impossible.
Most activities cannot be retroactively performed since they are closely
linked into the development lifecycle. Diligent, complete and correct
implementation of risk management from the start of product development
is therefore imperative.

This course will introduce all necessary steps to design, implement and
test critical medical devices in a regulatory compliant environment.
This course will additionally address the software risk management and
the resulting interfaces to device level risk management.

To comprehensively summarize all risk related activities and to
demonstrate the safe properties of a device the ‘Safety Case’ or
‘Assurance Case’ document is a well-established method to collect all
safety related information together in one place. This documentation
will most likely become mandatory for all devices (currently only
required for FDA infusion pump submissions).

This course will introduce the basic concepts and content of safety
assurance cases and will illustrate the usefulness for internal and
external review of safety related information.


Day 1 Schedule

Lecture 1:

Introduction into Risk Management and Quality System Integration

  • Why risk management?

    • Historical perspective
    • International regulatory / statutory requirements
  • Risk Management Lifecycle and stakeholders

    • Over-reaching concept
    • Integration into ISO13485
    • Lifecycle steps
  • Risk Management Benefits

    • Liability issues
    • Streamlining product development
    • Improving product safety and quality
  • How to Implement Risk Management into ISO13485

    • SOP framework
    • Planning and execution
    • Monitoring and control

Lecture 2:

Risk Management to ISO 14971:2012

  • Risk Management Planning
  • Risk Management Life Cycle
  • Hazard Identification

    • Hazard Domains
    • Hazard Latency Issues
    • Risk Rating Methods
  • Initial (unmitigated) Risk Assessment
  • Mitigation Strategies and Priorities
  • Mitigation Architectures

    • Alarm Systems as Mitigations
    • Risk Control Bundles
  • Post Mitigation Risk
  • Residual Risk

    • Safety Integrity Levels
  • European special requirements (Z-Annexes)
  • Safety Requirements
  • Hazard Mitigation Traceability
  • Verification Planning
  • Architectures, Redundancy and Diversity
  • Failure Mode and Effect Analysis
  • Tips and Tricks
  • Q&A

Day 2 Schedule

Lecture 1:

Usability and Risk Management

  • Use errors as hazard source
  • User intervention as hazard mitigation
  • Usability engineering lifecycle
  • Application specification
  • Usability Specification
  • Frequently used functions / primary operating functions
  • Usability verification / validation
  • Upcoming changes IEC62366:2014

Lecture 2:

Software Risk Management (IEC62304 / FDA software reviewers’

  • Critical Software Issues
  • Software Hazard Mitigation Strategies
  • Software Item, Unit and System Definition
  • Software Failures as Hazard Sources
  • Software Requirements and Design Specification
  • Software Tools and Development Environment

Lecture 3:

Software Risk Management (IEC62304 / FDA software reviewers’

  • Software Unit and Integration Testing
  • Real-Time System Challenges
  • Software Verification and Validation
  • Mitigation Traceability and Effectiveness
  • Software Maintenance and Configuration Control
  • Software Risk Management Process integration into ISO14971
  • Legacy Software issues
  • FDA documentation requirements
  • Upcoming changes in IEC62304:2014
  • Tips and Tricks

Lecture 4:

Safety / Assurance case

  • Safety classes

    • Basic Safety / Environment
    • Essential performance
  • Documentation of Basic Safety

    • Electrical Safety
    • Mechanical Safety
    • EMC / RFI safety
    • Safety margins
  • Documentation of essential performance

    • What is essential performance?
    • Device architectures and mitigation allocation
    • Device specific mitigations
    • Software mitigations
  • External safety

    • User intervention and alarms
    • Organizational measures
    • Levels of protection concept
  • Verification of safety properties

    • Type testing
    • Sample testing
    • Software verification testing
    • Inspections
    • Analyses
  • Assurance case vs. Risk Management Report

    • General safety and hazard avoidance
    • Device / application specific issues
  • Tips and Tricks
  • Q&A

For more information about this conference visit https://www.researchandmarkets.com/r/8uxr8w


Laura Wood, Senior Press Manager
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Topics: Medical


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