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Medical Device Makers Tackle FDA Rules with PLM
sponsored by CIO Decisions
Posted:  05 Mar 2007
Published:  01 Mar 2007
Format:  HTML
Length:  3  Page(s)
Type:  Journal Article

ABSTRACT:

Jeanne Iasella is governed by regulations. Iasella is the CIO at Medrad Inc., a $411-million company that makes devices for imaging and diagnostic procedures. And when Medrad makes a design change -- say, a plastic component is ditched in favor of a titanium one -- that change must be authorized by numerous people within the company and documented.

"Just to get the signatures of six people could take months," Iasella says.

As with all companies that make medical devices, Medrad must pay heed to the Food and Drug Administration (FDA), whose mandates cover everything from device design and manufacturing to marketing and processing complaints.
 
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AUTHOR: 

Megan Santosus
Senior Editor, CIO Decisions


BROWSE RELATED RESOURCES:
Business Performance Management | FDA | FDA Compliance | Health Care Industry | Life Sciences Industry | Manufacturing Execution Systems | PLM | PLM Software
View All Resources sponsored by CIO Decisions

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