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Featured Articles

February 2011

Ellen Leinfuss

Seven Signs that Your Quality Program is in Trouble

by Ellen Leinfuss
SVP, Life Science, Kaplan Eduneering

Product quality problems don't happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing.

Because of the unique nature of medical products and the expectations of prescribers and patients, failed product quality translates into a betrayal of trust. It is a safety and brand issue, and problems are on the rise, as evidenced by the 300 percent increase in drug recalls experienced this past year.

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Why Baldrige Works

by Rose Almon-Martin
V.P. Performance Excellence, MEDRAD, Warrendale, Pa.

There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 percent of target.

MEDRAD, a global market leader in radiology and interventional cardiology, measures success through our corporate Scorecard, which are five benchmarked goals that drive exceptional performance for our three stakeholders: customers, employees and our parent company, Bayer. The Baldrige Criteria helped MEDRAD consistently deliver results to stakeholders during times of growth and during tough times.

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Did You Know?

MD&M East
June 6-9, 2011, New York, NY

AdvaMed Annual Congress
September 26-28, 2011, Washington D.C.

RAPS Annual Conference and Exhibition
October 23-26, Indianapolis, IN

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On February 8th of this year the FDA announced Innovation Pathway, a new program dedicated to the priority review of new medical devices. The first submission selected for the program is an upper-extremity prosthetic that is controlled by the brain. This device is a pilot and will help determine the efficacy of the program. The FDA will also ask for additional public comment regarding the program before it is implemented on a widespread basis.
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