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Cardiovascular
FDA Reaches Agreement with Philips North America Over Quality Control Issues
Company must cease manufacturing until corrective action is taken.U.S. Food and Drug Administration 11.01.17
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Digital Health
The Future of Artificial Intelligence and Quality Management
Industry leaders are required to keep up with change. In regulated industries like the life sciences, ensuring the safety of all products—and therefore, the public—is a main priority. Change is the necessary component driving continuous i…Emily Ysaguirre, Content Marketing Writer, EtQ 10.05.17
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Software & IT
Quality Nightmares #25
Quality Nightmares offers a humorous look at the challenges faced by medtech professionals.MasterControl 08.22.17
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Contract Manufacturing | Materials | Software & IT
A Holistic Approach to Quality and Supplier Management
Those who outsource to fulfill manufacturing needs already know that suppliers are an integral part of a company’s operations. In fact, the relationships with suppliers might be some of the most influential a company will make. So how does one…Alexa Sussman, EtQ 07.20.16
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Materials | R&D & Design | Software & IT
How Automation Ensures Improvement: Change Management in Quality Management Systems
Change is common within the life sciences industry, where a product may be designed only once but change occurs often throughout the product lifecycle. An organization’s ability to incorporate quality into every aspect of a change results in ov…Brenda Percy, EtQ Inc. 04.06.16
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Contract Manufacturing | Materials | Molding | Software & IT
The Over/Under on Quality
Quality is imperative to a device’s success, but anxiety over perfection can paralyze.Ranica Arrowsmith, Associate Editor 10.14.15
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Contract Manufacturing | R&D & Design | Testing
Meeting OEM's New Standards for Quality
The word “quality” has been applied so ubiquitously in the medical device industry that some argue the term has lost its influence to differentiate one company from another. The reality, however, is that as compliance requirements have in…Angel Domingo, Joe Rotino and Vu Doan 06.11.12
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Materials | R&D & Design | Software & IT
Quality Perspectives: Change and Quality Management are Necessities for Businesses
Change and quality management are necessities for businesses.Brenda Percy 02.04.09
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R&D & Design | Testing
Quality Inspection Sampling Procedure
Since the introduction of the surveillance program, the SFDA and CDR have implemented quality inspection programs for products on the market. Under the CDR’s supervision, inspectors take samples of selected product categories from the manufac…Chang-Hong Whitney 10.21.06
