RAPS Approved Webinar
Safety Critical Software - Software Risk Management
Date & Time: Course "Safety Critical Software - Software Risk Management" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full
completion. Instructor Profile: Thursday, October 4, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Markus Weber
Price : $245.00
Markus Weber Principal Consultant, System Safety Inc.
(for one participant)
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.
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 softwarecontrolled 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. ...more
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Areas Covered in the Session: l l l l l l l l l l l
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)
Click here to register for this webinar Who Will Benefit: l
Regulatory / Quality Control Software engineering
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Published on Oct 3, 2012
Overview: Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requi...