Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) PDF Download
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Author: Joy Frestedt Publisher: Elsevier ISBN: 0443220646 Category : Computers Languages : en Pages : 547
Book Description
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing
Author: Joy Frestedt Publisher: Elsevier ISBN: 0443220646 Category : Computers Languages : en Pages : 547
Book Description
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing
Author: Paul G. Thomas Publisher: ANU E Press ISBN: 1920942793 Category : Business & Economics Languages : en Pages : 86
Book Description
Identifies the ways that politics enters into the creation of performance measurement systems, the selection of the official and unofficial aims of such systems, the selection of performance criteria and measures, the interpretation of findings, the responses to such findings and the implications of performance reporting.
Author: Department of Health & Human Services Publisher: CreateSpace ISBN: 9781499706499 Category : Medical Languages : en Pages : 40
Book Description
Over the past decade, a growing body of research and online resources has emerged to provide guidance on effective practices for publicly reporting information on provider performance for consumers. These recommendations are for the most part evidence based and assume that an effective report is one that contains performance information that consumers understand and find both credible and relevant. In addition, information is conveyed in a way that makes it as easy as possible for consumers to use it to make good choices among providers. Another key audience for performance reporting is physicians themselves. Health plans and medical groups have sponsored private physician “performance feedback” reports for many years, with the intention of supporting internal quality improvement efforts as well as patient care management. More recently, multistakeholder community quality collaboratives, including roughly half of the Chartered Value Exchanges (CVEs) supported by the Agency for Healthcare Research and Quality (AHRQ), have begun to produce some type of private report for physicians in parallel to their public report for consumers. These groups recognize that a single report designed for one audience cannot meet the needs of both. In addition, the Centers for Medicare & Medicaid Services (CMS) has sponsored pilot studies of the effects of providing individual physicians and medical groups with performance feedback based on claims data and CMS's Physician Quality Reporting System. In contrast with public reports, private reports are often confidential and limited in distribution to those with a “need to know.” Thus, little research even of a descriptive nature has been conducted on the various forms that private reporting has taken. Limited discussion of how to define and measure the effectiveness of such reports and little published evaluation research are available. Therefore, the science of private “feedback reporting” for physicians is nascent at best. As CVEs and other community quality collaboratives consider strategies for private feedback reporting to physicians and other health care providers, they will need to address basic issues such as report design and distribution. They also will need to examine their role in relation to existing and planned internal performance reporting activities of the health systems and medical practices in their markets. In contrast to public reporting for consumers, where the role of a neutral, multistakeholder collaborative is relatively well accepted as a source of objective, communitywide performance data, the role of community collaboratives in private feedback reporting is not always so clearly defined. Many health plans and health systems, which may themselves be collaborative members, have developed very sophisticated internal reporting systems of their own based on electronic health records. In the context of these and other private performance reporting initiatives, community collaboratives will need to determine the unique value-added features that their private feedback reports can provide. The goal is to complement rather than compete with reports from their provider members or other report sponsors. This resource document is intended to provide practical information and guidance primarily to CVEs and other community quality collaboratives interested in the design, dissemination, and use of private feedback reports on physician performance.
Author: United States. Rehabilitation Services Administration. Division of Monitoring and Program Analysis. Statistical Analysis and Systems Branch Publisher: ISBN: Category : Rehabilitation Languages : en Pages : 56
Author: Joy Frestedt
Author: Joy Frestedt
Author: Paul G. Thomas
Author: United States. Patent and Trademark Office
Author: Department of Health & Human Services
Author: United States. Rehabilitation Services Administration. Division of Monitoring and Program Analysis. Statistical Analysis and Systems Branch
Author: 
Author: Dail D. Doucette
Author: National Science Foundation (U.S.)
Author: United States. Farm Credit Administration
Author: