Software Risk Management (Philidelphia, PA, United States - September 24-25, 2018)

  • ID: 4535566
  • Conference
  • Location: Philidelphia, PA, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: September 24-25, 2018
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Course "Software Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.

Why you should attend:
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 requirements for development of safety-critical software used in medical devices is the content of this seminar.

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Day 1 Schedule

Lecture 1 (90 Mins):
Legal and regulatory requirements for risk management
Risk management and quality 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
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)

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  • Markus Weber Markus Weber,
    Principal Consultant ,
    System Safety Inc.

    Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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  • Project managers
  • Software Engineers
  • Regulatory specialists
  • Quality assurance specialists
  • Documentation specialists
  • Test managers
  • Software team leaders and lead developers
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DoubleTree by Hilton Philidelphia Airport
4509 Island Avenue
Philidelphia, PA
United States


From Philadelphia International Airport, 
8000 Essington Ave, Philadelphia, PA 19153, USA:
Take Garage Access Rd, Exit 13 and Island Ave to Executive Ave,
8 min (3.5 mi)-
Continue on Executive Ave. Drive to Island Ave,
1 min (0.3 mi)-
Turn right onto Island Ave,
Destination will be on the right,
52 s (0.3 mi)-
DoubleTree by Hilton Philadelphia Airport,
4509 Island Ave, Philadelphia, PA 19153, USA.

Note: Product cover images may vary from those shown