RAPS pre-approved webinar on

(prHWY.com) September 5, 2012 - Wilmington, DE -- Description: Basic questions that arise when dealing with software lifecycle, some of the standard questions that crop up are:
o What is a software unit?
o How much and what kind of detail does the requirement specification need?
o Without test harnesses, how can integration testing be performed?
This webinar will detail how all these risk dependent activities and documentation requirements can be explained using IEC62304, the internationally recognized software lifecycle standard. It will be a practical guidance on how a development process that is both streamlined and compliant can be employed.
Some of the areas this webinar will cover include:
o Software criticality classes
o Software requirements specification
o How to write meaningful requirements
o Software architectures
o Multi software system implementation
o Software design documentation
o Requirements traceability
o Software unit and integration testing
o Software testing in real-time systems
o Software tools
o SOUP (software of unknown providence)
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When: October 4, 10:00 AM PDT | 01:00 PM EDT
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By whom: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 an 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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For whom:
The webinar will benefit professionals in
o Project Management
o Regulatory / Quality Control
o Software engineering
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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