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Meet MAUDE

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FDA Guidance Advises Device Makers to Think About Home Use

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Quality of Nation’s Healthcare ‘Fair’ But Slowly Improving

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For the 11th consecutive year, the Agency for Healthcare Research and Quality has released complementary reports that assess the U.S. healthcare system’s performance in the areas of healthcare quality, access, and disparities in care.

Is Your Medical Device ‘State of the Art?’

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Yes
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Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

Healthcare of the Future

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Recipe for Success: Food Safety Regulations and the Role of Quality Management

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Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.

Sensors May Keep Hospitalized Patients From Falling

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For the Good of the Community

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In health care settings, clinical integration is a fairly new concept that means coordinating patient care across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-focused. 

Baldrige Winner Sutter Davis Hospital Pursues Outstanding Patient Experience

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The Beginning of the End for Fake ISO 13485 Certificates

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Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.

Pagination

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