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2 Day Course: Software Risk Management (Philadelphia, PA, United States - July 19-20, 2018) - ResearchAndMarkets.com
[May 15, 2018]

2 Day Course: Software Risk Management (Philadelphia, PA, United States - July 19-20, 2018) - ResearchAndMarkets.com


The "Software Risk Management" conference has been added to ResearchAndMarkets.com's offering.

The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.

Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC (News - Alert) requirements for development of safety-critical software used in medical devices is the content of this seminar.

Agenda

Day 1 Schedule

Lecture 1 (90 Mins)

  • Legal and regulatory requirements for risk management
  • Risk management and qualiy systems



Lecture 2 (90 Mins)

  • Risk Management Basics
  • What are hazards / hazardous situations
  • Hazard characteristics
  • Risk and risk rating
  • Residual risk

Lecture 3 (90 Mins)


  • Software failures
  • Random and systematic faults
  • Fault control means
  • Software failure effects

Lecture 4 (90 Mins)

  • System Architectures
  • Software Architecture
  • Software Tools and Methods
  • Multiprocessor systems
  • Real-time challenges

Day 2 Schedule

Lecture 1 (90 Mins)

  • Software Criticality Classification
  • IEC criticality classed
  • FDA level of concern

Lecture 2 (90 Mins)

  • The 62304 Development Process
  • Life Cycle
  • Documentation
  • Comparison to FDA requirements

Lecture 3 (90 Mins)

  • Software Risk Management
  • Software Configuration Management
  • Software Problem Resolution
  • Software Maintenance

Lecture 4 (90 Mins)

  • Legacy Software
  • Risk-based verification
  • Third-party software (SOUP, COTS)

For more information about this conference visit https://www.researchandmarkets.com/research/kn5qkz/2_day_course?w=4


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