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Behavioral Tolerance
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Medical Device Design and Regulation
The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a ro...
Actionable Performance Measurement
Measurement is absolutely essential for any organization or company, functional area, department, business unit, project, or individual. Companies must know how their processes are performing, how well they are meeting customers’ needs, how targeted improvements are being achieved, and how management is doing. Accurate performance measures tell companies where they are, and to take action if they are not on track or if performance does not meet expectations.Actionable Performance Measurement presents many different methods to help readers develop metrics and performance measures. To aid in corporate measures development and strategic, tactical and/or business planning, a quick and effec...
The Rise and Fall of Synanon
The definitive account of Synanon. On a fall day in 1978, Los Angeles attorney Paul Morantz reached into his mailbox to collect his mail and was nearly killed. He was bitten by the four-foot-long rattlesnake that had been put there by members of a cultlike group called Synanon. Chuck Dederich—a former Alcoholics Anonymous member who coined the phrase "Today is the first day of the rest of your life"—established Synanon as an innovative drug rehabilitation center near the Santa Monica beach in 1958. Synanon quickly evolved into an experimental commune and religion that attracted thousands of members and was strongly committed to social justice and progressive education. Twenty years later...
Measurement Matters
Many organizations still operate with an all-too-familiar polarization between managers and employees. The work of employees is checked, measured, audited, and rechecked. Incentive programs, quotas, and evaluations are doggedly adhered to. And often, as a result, resources are wasted, morale plummets, and defects actually increase. Why exactly does this system continue to run amok? What is an effective alternative? By installing an effective assessment process that successfully measures employee performance without impeding production, the organization can become more efficient and employee satisfaction increases. Measurement Matters builds on the principles of Dr. W. Edwards Deming, as w...
The Textile Mercury
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