Safety Critical Software - Software Risk Management

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

Subscribe Newsletter

Main
Safety Critical Software - Software Risk Management

Safety Critical Software - Software Risk Management

| |

Instructor : Markus Weber

Product Id : 600641

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

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.

Related Webinars:

No Related Webinars Available