Quality Control
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2018.03.27
Faulty Seal Blamed for Sterlimed Agilis Recall
FDA has identified the recall as a Class I, the most serious type of medical device recall.
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Philips Forced to Stop Making AEDs Until Problems are Fixed
FDA and Philips reached an agreement regarding manufacturing issues involving the company’s automatic external defibrillators.
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Medtronic Exec: How to Move Past Compliance to Quality
The medical device industry has had a tough time recently when it comes to its reputation for addressing defects.
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IQ, OQ and PQ: The Backbone of Your Quality System
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
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2018.03.23
The Necessary Overhead of Quality Processes in Medical Device Product Development
The Necessary Overhead of Quality Processes in Medical Device Product Development
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2018.03.20
Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
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2018.03.01
What if FDA and Medtech Worked Together on Quality?
An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.
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