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Safety Critical Software - Software Risk Management

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$225.00
  • Refund Policy

Overview:

Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained.

Questions like:

How much detail is required in the requirement specification?

What is a software unit?

How can integration testing be performed without test harnesses? Will be answered.

Practical guidance on how to employ a streamlined but yet compliant development process will be given.

Why should you attend: This webinar will explain basic design control concepts and the criticality dependent requirements for software development. Software specification, architectures and resulting design documentation will be discussed, as well as practical tips on how to streamline the development process and minimize the regulatory burden.

Areas Covered in the Session:
  • Software criticality classes
  • Software requirements specification
  • How to write meaningful requirements
  • Software architectures
  • Multi software system implementation
  • Software design documentation
  • Requirements traceability
  • Software unit and integration testing
  • Software testing in real-time systems
  • Software tools
  • SOUP (software of unknown providence)

Who Will Benefit:
  • Project Management
  • Regulatory / Quality Control
  • Software engineering
Speaker Profile
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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