Medical Devices: Measurements, Quality Assurance, and Standards PDF Download
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Author: Cesar Augusto Caceres
Publisher: ASTM International
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 319
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Book Description
Author: Cesar Augusto Caceres
Publisher: ASTM International
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 319
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Book Description
Author: Barbara J. Bain
Publisher: Elsevier Health Sciences
ISBN: 0702069256
Category : Medical
Languages : en
Pages : 599
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Book Description
For more than 65 years, this best-selling text by Drs. Barbara J. Bain, Imelda Bates, and Mike A. Laffan has been the worldwide standard in laboratory haematology. The 12th Edition of Dacie and Lewis Practical Haematology continues the tradition of excellence with thorough coverage of all of the techniques used in the investigation of patients with blood disorders, including the latest technologies as well as traditional manual methods of measurement. You'll find expert discussions of the principles of each test, possible causes of error, and the interpretation and clinical significance of the findings. - A unique section on haematology in under-resourced laboratories. - Ideal as a laboratory reference or as a comprehensive exam study tool. - diagnosis, molecular testing, blood transfusion- and much more. - Complete coverage of the latest advances in the field. - An expanded section on coagulation now covers testing for new anticoagulants and includes clinical applications of the tests.
Author:
Publisher: BoD – Books on Demand
ISBN: 0850140242
Category : Technology & Engineering
Languages : en
Pages : 312
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Book Description
In any engineering field (including manufacturing, construction, transportation, aerospace, food and agriculture, oil and gas, etc.), ensuring product quality is fundamental to achieving success. Quality assurance (QA) and quality control (QC) are integral components of managing quality. According to the American Society for Quality (ASQ), QA is defined as the part of quality management that focuses on instilling confidence in meeting quality requirements, while QC is concerned with fulfilling those requirements. QA instills confidence internally within the engineering organization’s management and externally with customers, government agencies, regulators, certifiers, and other stakeholders. QA primarily examines how processes are carried out or how products are made, while QC concentrates on product inspection. When QA and QC collaborate effectively, organizational efficiency is enhanced, resulting in superior products. Quality Control and Quality Assurance - Techniques and Applications explores various aspects of quality, including quality planning, QC, QA, and quality enhancement. It covers topics related to QA such as total quality management (TQM), failure testing, process and product quality assurance (PPQA), and statistical process control (SPC). QC includes chapters describing process control, control charts, acceptance sampling, and product quality assessment. For meaningful and easy traceability, the chapters are divided into four sections: “Basics of QA/QC”; “Applications of QA/QC in Industry”; “Applications of QA/QC in Healthcare”; and “Applications of QA/QC in Education”. Covering the latest practices, techniques, and applications in QC and QA, this book is a valuable resource for engineering and business students, practicing engineers, engineering managers, and third-party agencies.
Author: Almir Badnjević
Publisher: Springer
ISBN: 9811066507
Category : Technology & Engineering
Languages : en
Pages : 285
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Book Description
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 988
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 0788104098
Category :
Languages : en
Pages : 60
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Book Description
Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0
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Book Description
Author: Ray Tricker
Publisher: Routledge
ISBN: 1136391088
Category : Business & Economics
Languages : en
Pages : 341
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Book Description
In order to meet the recommendations, requirements and specifications of ISO 9001:2000, organisations must undertake an audit of their own quality procedures and those of their suppliers. Likewise, when supplying ISO 9001:2000 accredited customers, suppliers must be prepared to undergo a similar audit. Revised, updated and expanded, ISO 9001:2000 Audit Procedures describes the methods for completing management reviews and quality audits, and outlines the experiences of working with 9001:2000 since its launch in 2000. It also includes essential new material on process models, generic pocesses, the requirements for mandatory documented procedures, and detailed coverage of auditors questionnaires.
Author:
Publisher:
ISBN:
Category : Medical care
Languages : en
Pages : 116
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Book Description
Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 338
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Book Description
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
