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    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
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    RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers

    RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious , by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories . Topics Sherman covers in Eclectic Science include mindful...
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    Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

    Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device manufacturers have to interpret broad and varying definitions within FDA’s regulations and a related guidance document on the topic. Until now, there has been no comprehensive resource to help regulatory and quality professionals, and other stakeholders navigate device validatio...
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    Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

    The following chapter is an excerpt taken from The Medical Device Validation Handbook . Process and Design Validation—Regulatory Concerns Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process can be validated with a high degree of assurance and approved according to established procedures, as required by 2...
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    The Science Behind What You See

    No other sense organ is as critically important to the activities of daily living as our eyes. This article, which describes sight and the vision process, is the third in a series the author is writing about the five senses. Articles on hearing and smell were published in Regulatory Focus in 2013. 1,2 This article briefly discusses eye anatomy, the miracle of vision, the evolution of sight and ocular diseases (cataracts in particular), and provides references for furth...
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    Bacillus Calmette-Guerin--Another Surprise!

    • 19 October 2012
    After a physical several years ago, my wife learned that red and white blood cells were detected in her urine. The doctor ordered an intravenous pyelogram to determine the cause. In this test, an iodine-containing contrast material is injected into the bloodstream and a series of X-rays are then taken at timed intervals. The resulting films allow the radiologist to view the entire urinary tract. Unfortunately, the diagnosis revealed evidence of bladder cancer, a well-di...
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    Lister and Semmelweis - Two Misunderstood Geniuses

    • 17 July 2012
    In a recent The New England Journal of Medicine review of the past 200 years of surgery, author Atul Gawande, MD, MPH, mentioned that Joseph Lister's seminal work on antisepsis was regarded with overwhelming skepticism by the medical profession. 1 This was despite the fact Lister's work was heralded in a series of articles he wrote for The Lancet . However, this same journal found the alleged breakthrough as a method neither original nor beneficial. 2 Ignac Semmelw...
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    Bloodletting and Malariatherapy: Treatment Methods of the Past

    • 26 April 2012
    Those interested in the history of medicine should read the details surrounding the therapy rendered to President George Washington by his physicians in December 1799. 1 Purging, bloodletting and other methods were employed, which hastened his death. His treatment was also discussed recently in the New England Journal of Medicine 's 200 th Anniversary issue. 2 The authors used Washington's experience as a benchmark for measuring the remarkable progress medicine has ...