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
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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
Get Book Here
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: Julian P. T. Higgins
Publisher: Wiley
ISBN: 9780470699515
Category : Medical
Languages : en
Pages : 672
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Book Description
Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.
Author: Aota
Publisher: AOTA Press
ISBN: 9781569003619
Category : Medical
Languages : en
Pages : 51
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Book Description
As occupational therapy celebrates its centennial in 2017, attention returns to the profession's founding belief in the value of therapeutic occupations as a way to remediate illness and maintain health. The founders emphasized the importance of establishing a therapeutic relationship with each client and designing an intervention plan based on the knowledge about a client's context and environment, values, goals, and needs. Using today's lexicon, the profession's founders proposed a vision for the profession that was occupation based, client centered, and evidence based--the vision articulated in the third edition of the Occupational Therapy Practice Framework: Domain and Process. The Framework is a must-have official document from the American Occupational Therapy Association. Intended for occupational therapy practitioners and students, other health care professionals, educators, researchers, payers, and consumers, the Framework summarizes the interrelated constructs that describe occupational therapy practice. In addition to the creation of a new preface to set the tone for the work, this new edition includes the following highlights: a redefinition of the overarching statement describing occupational therapy's domain; a new definition of clients that includes persons, groups, and populations; further delineation of the profession's relationship to organizations; inclusion of activity demands as part of the process; and even more up-to-date analysis and guidance for today's occupational therapy practitioners. Achieving health, well-being, and participation in life through engagement in occupation is the overarching statement that describes the domain and process of occupational therapy in the fullest sense. The Framework can provide the structure and guidance that practitioners can use to meet this important goal.
Author: Transportation Research Board
Publisher: Transportation Research Board
ISBN: 0309094984
Category : Business & Economics
Languages : en
Pages : 269
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Book Description
TRB Special Report 282: Does the Built Environment Influence Physical Activity? Examining the Evidence reviews the broad trends affecting the relationships among physical activity, health, transportation, and land use; summarizes what is known about these relationships, including the strength and magnitude of any causal connections; examines implications for policy; and recommends priorities for future research.
Author: Paul C. Cozby
Publisher: WCB/McGraw-Hill
ISBN:
Category : Psychology
Languages : en
Pages : 300
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Book Description
For undergradute social science majors. A textbook on the interpretation and use of research. Annotation copyright Book News, Inc. Portland, Or.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231
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Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Author: Mark Petticrew
Publisher: John Wiley & Sons
ISBN: 1405150149
Category : Psychology
Languages : en
Pages : 352
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Book Description
Such diverse thinkers as Lao-Tze, Confucius, and U.S. Defense Secretary Donald Rumsfeld have all pointed out that we need to be able to tell the difference between real and assumed knowledge. The systematic review is a scientific tool that can help with this difficult task. It can help, for example, with appraising, summarising, and communicating the results and implications of otherwise unmanageable quantities of data. This book, written by two highly-respected social scientists, provides an overview of systematic literature review methods: Outlining the rationale and methods of systematic reviews; Giving worked examples from social science and other fields; Applying the practice to all social science disciplines; It requires no previous knowledge, but takes the reader through the process stage by stage; Drawing on examples from such diverse fields as psychology, criminology, education, transport, social welfare, public health, and housing and urban policy, among others. Including detailed sections on assessing the quality of both quantitative, and qualitative research; searching for evidence in the social sciences; meta-analytic and other methods of evidence synthesis; publication bias; heterogeneity; and approaches to dissemination.
Author: Great Britain. Board of Trade
Publisher:
ISBN:
Category : Load-line
Languages : en
Pages : 98
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Book Description
Author: United States. Department of Health, Education, and Welfare. Secretary's Advisory Committee on Automated Personal Data Systems
Publisher:
ISBN:
Category : Business records
Languages : en
Pages : 396
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Book Description
Author: International Labour Office
Publisher: International Labor Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 440
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Book Description
The International Standard Classification of Occupations 2008 (ISCO-08) is a four-level hierarchically structured classification that covers all jobs in the world. Developed with the benefit of accumulated national and international experience as well as the help of experts from many countries and agencies, ISCO-08 is fully supported by the international community as an accepted standard for international labour statistics. ISCO-08 classifies jobs into 436 unit groups. These unit groups are aggregated into 130 minor groups, 43 sub-major groups and 10 major groups, based on their similarity in terms of the skill level and skill specialisation required for the jobs. This allows the production of relatively detailed internationally comparable data as well as summary information for only 10 groups at the highest level of aggregation. Each group in the classification is designated by a title and code number and is associated with a definition that specifies the scope of the group. The classification is divided into two volumes: Volume I presents the structure and definitions of all groups in ISCO-08 and their correspondence with ISCO-88, which it supersedes, while Volume II provides an updated and expanded index of occupational titles and associated ISCO-08 and ISCO-88 codes.
