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Why FMEA Is <em>Not</em> ISO 14971

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HIPAA Audits Are Coming! HIPAA Audits Are Coming!

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Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.

Lean Six Sigma Applications in Healthcare

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Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.

Nation Should Implement a Medical Device Evaluation System

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Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.

Researchers Develop First Widely Useful Standard for Breast MRI

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Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.

Addressing Human Factors Relating to Combination Products

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Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority.

Border Crossings

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Amping Antimicrobial Discovery With Automation

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How ISO 9001:2015 Helps Improve Customer Relationships

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Health Plan Member Satisfaction Climbs

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According to the recently released J.D. Power 2016 Member Health Plan Study, critical factors of health plan member satisfaction are highest in areas of the country that have more competition between different health plans.

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