SOURCE: Intertech

August 28, 2006 10:09 ET

Medical Device Software Validation for Non-Software Engineers Will Be Covered at Medtec Ireland Workshop

Intertech Engineering Associates' David Vogel Speaks Sept. 20

NORWOOD, MA -- (MARKET WIRE) -- August 28, 2006 -- Non-software engineers can handle most software validation for medical devices, and a workshop at Medtec Ireland will teach them how to validate quality, design, development, and manufacturing-system software.

David Vogel, PhD, president of Intertech Engineering Associates, will cover

--  Regulatory background and requirements for validating quality-system
    software
--  FDA guidances on quality-system software validation
--  Validation components
--  How to determine if software is regulated or not
--  Using risk management to drive validation efforts
--  Determining how much validation is recommended
--  Dealing with off-the-shelf, custom, and hybrid software packages
--  Validation of Part 11 software
    
The course is designed for the non-software engineer who has the responsibility for validating quality-system software regulated by 21 CFR 820.70(i). It makes extensive use of instruction by example from lecturer's experience in the medical device industry and as a member of an AAMI workgroup.

Attendees are encouraged bring in real-world examples from their jobs.

Medtech Ireland will be held in Galway. More info at http://www.devicelink.com/expo/medtire06/conference_101pm.html

Intertech (www.inea.com) serves the medical device industry by providing electronics hardware and software development services. Vogel and his Intertech team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have a 100% safety record.

Vogel holds PhD in biomedical engineering from the University of Michigan.

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