Author: Thomas Pyzdek
Publisher: McGraw-Hill Companies
ISBN: 9781265829230
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The definitive guide to organizational excellence--completely updated Fully revised for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/QE) Body of Knowledge, The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition offers in-depth guidance on effectively applying the principles of quality management in today's business environment and delivering superior results. Designed to help you prepare for and pass the ASQ CMQ/QE exam, this authoritative volume also serves as an essential on-the-job reference. Coverage includes: Business-integrated quality systems Organizational structures The quality function Approaches to quality Customer-focused organizations Integrated planning Strategic planning Understanding customer expectations and needs Benchmarking Organizational assessment Process control Quantifying process variation Quality audits Supply chain management Continuous improvement Effective change management Six Sigma methodology, including detailed descriptions of the DMAIC and DMADV approaches Management of human resources Motivation theories and principles Management styles Resource requirements to manage the quality function Over the past 40 years, the quality management discipline has undergone steady evolution from disparate quality assurance efforts to strategic, business-integrated functions. Today's quality manager must be able to plan and implement measurable, cost-effective process-improvement initiatives across the organization. Written by two of the foremost authorities on the subject and fully updated for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Body of Knowledge, The Handbook for Quality Management, Second Edition provides an operational guide to the proper understanding and application of quality management in the current business environment. It serves as a primary reference source for an organization's quality program and for anyone seeking to pass the CMQ/OE exam, given by the ASQ. The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition: Clearly defines quality management principles and their application within a cross section of industries Integrates the application of Theory of Constraints, Six Sigma, and Lean thinking into the Quality Management discipline Contains detailed methods for planning, including customer needs recognition, benchmarking, and organizational assessments Discusses controls such as statistical process control, audits, and supply chain management Explains the stages of continuous improvement Incorporates classic motivation theory with more current management practices advocated by Joiner, Senge, and Deming, among others
The Handbook of Quality Management 2e (Pb)
Author: Thomas Pyzdek
Publisher: McGraw-Hill Companies
ISBN: 9781265829230
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The definitive guide to organizational excellence--completely updated Fully revised for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/QE) Body of Knowledge, The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition offers in-depth guidance on effectively applying the principles of quality management in today's business environment and delivering superior results. Designed to help you prepare for and pass the ASQ CMQ/QE exam, this authoritative volume also serves as an essential on-the-job reference. Coverage includes: Business-integrated quality systems Organizational structures The quality function Approaches to quality Customer-focused organizations Integrated planning Strategic planning Understanding customer expectations and needs Benchmarking Organizational assessment Process control Quantifying process variation Quality audits Supply chain management Continuous improvement Effective change management Six Sigma methodology, including detailed descriptions of the DMAIC and DMADV approaches Management of human resources Motivation theories and principles Management styles Resource requirements to manage the quality function Over the past 40 years, the quality management discipline has undergone steady evolution from disparate quality assurance efforts to strategic, business-integrated functions. Today's quality manager must be able to plan and implement measurable, cost-effective process-improvement initiatives across the organization. Written by two of the foremost authorities on the subject and fully updated for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Body of Knowledge, The Handbook for Quality Management, Second Edition provides an operational guide to the proper understanding and application of quality management in the current business environment. It serves as a primary reference source for an organization's quality program and for anyone seeking to pass the CMQ/OE exam, given by the ASQ. The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition: Clearly defines quality management principles and their application within a cross section of industries Integrates the application of Theory of Constraints, Six Sigma, and Lean thinking into the Quality Management discipline Contains detailed methods for planning, including customer needs recognition, benchmarking, and organizational assessments Discusses controls such as statistical process control, audits, and supply chain management Explains the stages of continuous improvement Incorporates classic motivation theory with more current management practices advocated by Joiner, Senge, and Deming, among others
Publisher: McGraw-Hill Companies
ISBN: 9781265829230
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The definitive guide to organizational excellence--completely updated Fully revised for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/QE) Body of Knowledge, The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition offers in-depth guidance on effectively applying the principles of quality management in today's business environment and delivering superior results. Designed to help you prepare for and pass the ASQ CMQ/QE exam, this authoritative volume also serves as an essential on-the-job reference. Coverage includes: Business-integrated quality systems Organizational structures The quality function Approaches to quality Customer-focused organizations Integrated planning Strategic planning Understanding customer expectations and needs Benchmarking Organizational assessment Process control Quantifying process variation Quality audits Supply chain management Continuous improvement Effective change management Six Sigma methodology, including detailed descriptions of the DMAIC and DMADV approaches Management of human resources Motivation theories and principles Management styles Resource requirements to manage the quality function Over the past 40 years, the quality management discipline has undergone steady evolution from disparate quality assurance efforts to strategic, business-integrated functions. Today's quality manager must be able to plan and implement measurable, cost-effective process-improvement initiatives across the organization. Written by two of the foremost authorities on the subject and fully updated for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Body of Knowledge, The Handbook for Quality Management, Second Edition provides an operational guide to the proper understanding and application of quality management in the current business environment. It serves as a primary reference source for an organization's quality program and for anyone seeking to pass the CMQ/OE exam, given by the ASQ. The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition: Clearly defines quality management principles and their application within a cross section of industries Integrates the application of Theory of Constraints, Six Sigma, and Lean thinking into the Quality Management discipline Contains detailed methods for planning, including customer needs recognition, benchmarking, and organizational assessments Discusses controls such as statistical process control, audits, and supply chain management Explains the stages of continuous improvement Incorporates classic motivation theory with more current management practices advocated by Joiner, Senge, and Deming, among others
ISO 9001
Author: Itay Abuhav
Publisher: CRC Press
ISBN: 9781032240428
Category :
Languages : en
Pages : 444
Book Description
This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in th
Publisher: CRC Press
ISBN: 9781032240428
Category :
Languages : en
Pages : 444
Book Description
This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in th
Laboratory Quality Management System
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
The Process Management Memory Jogger
Author: Robert D. Boehringer
Publisher: Goal/QPC
ISBN: 9781576811085
Category : Business & Economics
Languages : en
Pages : 0
Book Description
Publisher: Goal/QPC
ISBN: 9781576811085
Category : Business & Economics
Languages : en
Pages : 0
Book Description
ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard
Author: David Hoyle
Publisher: Taylor & Francis
ISBN: 1317282280
Category : Business & Economics
Languages : en
Pages : 893
Book Description
Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs. Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance. Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes: Graphics and text boxes to illustrate concepts, and points of contention; Explanations between the differences of the 2008 and 2015 versions of ISO 9001; Examples of misconceptions, inconsistencies and other anomalies; Solutions provided for manufacturing and service sectors. This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses. Don’t waste time trying to achieve certification without this tried and trusted guide to improving your business – let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!
Publisher: Taylor & Francis
ISBN: 1317282280
Category : Business & Economics
Languages : en
Pages : 893
Book Description
Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs. Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance. Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes: Graphics and text boxes to illustrate concepts, and points of contention; Explanations between the differences of the 2008 and 2015 versions of ISO 9001; Examples of misconceptions, inconsistencies and other anomalies; Solutions provided for manufacturing and service sectors. This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses. Don’t waste time trying to achieve certification without this tried and trusted guide to improving your business – let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!
Standards for Management Systems
Author: Herfried Kohl
Publisher: Springer Nature
ISBN: 3030358321
Category : Business & Economics
Languages : en
Pages : 819
Book Description
This book guides readers through the broad field of generic and industry-specific management system standards, as well as through the arsenal of tools that are needed to effectively implement them. It covers a wide spectrum, from the classic standard ISO 9001 for quality management to standards for environmental safety, information security, energy efficiency, business continuity, laboratory management, etc. A dedicated chapter addresses international management standards for compliance, anti-bribery and social responsibility management. In turn, a major portion of the book focuses on relevant tools that students and practitioners need to be familiar with: 8D reports, acceptance sampling, failure tree analysis, FMEA, control charts, correlation analysis, designing experiments, estimating parameters and confidence intervals, event tree analysis, HAZOP, Ishikawa diagrams, Monte Carlo simulation, regression analysis, reliability theory, data sampling and surveys, testing hypotheses, and much more. An overview of the necessary mathematical concepts is also provided to help readers understand the technicalities of the tools discussed. A down-to-earth yet thorough approach is employed throughout the book to help practitioners and management students alike easily grasp the various topics.
Publisher: Springer Nature
ISBN: 3030358321
Category : Business & Economics
Languages : en
Pages : 819
Book Description
This book guides readers through the broad field of generic and industry-specific management system standards, as well as through the arsenal of tools that are needed to effectively implement them. It covers a wide spectrum, from the classic standard ISO 9001 for quality management to standards for environmental safety, information security, energy efficiency, business continuity, laboratory management, etc. A dedicated chapter addresses international management standards for compliance, anti-bribery and social responsibility management. In turn, a major portion of the book focuses on relevant tools that students and practitioners need to be familiar with: 8D reports, acceptance sampling, failure tree analysis, FMEA, control charts, correlation analysis, designing experiments, estimating parameters and confidence intervals, event tree analysis, HAZOP, Ishikawa diagrams, Monte Carlo simulation, regression analysis, reliability theory, data sampling and surveys, testing hypotheses, and much more. An overview of the necessary mathematical concepts is also provided to help readers understand the technicalities of the tools discussed. A down-to-earth yet thorough approach is employed throughout the book to help practitioners and management students alike easily grasp the various topics.
The Complete Guide to the ABC Molecular Biology Certification Exam
Author: Tiffany Roy
Publisher: CRC Press
ISBN: 1498753930
Category : Law
Languages : en
Pages : 241
Book Description
In 2009, the National Academy of Sciences (NAS) authored the report Strengthening Forensic Science in the United States: A Path Forward. In it, the Committee expressed the need for accreditation and certification. Accreditation, long recognized by public labs as an important benchmark in quality, was recognized as an important way to standardize laboratories that provide forensic services. Certification can play an important role as a method of oversight in the forensic sciences—something also recommended by the - National Commission on Forensic Science in October 2014. The Complete Guide to the ABC's Molecular Biology is a professional certification examination preparation text for forensic scientists taking the American Board of Criminalistics Examination in Molecular Biology. The book serves as a resource for forensic scientists—who are facing more and more pressure to become certified—to support them in their pursuit of forensic certification. In the years since the NAS report was published, there has been increased discussion of forensic certification requirements. ABC’s Molecular Biology exam is a quality certification, and learning the concepts for it will invariably help any professional working in the field. The book prepares readers in all relevant topic areas, including: accreditation, safety, biological screen principles, anatomy and cell biology, crime scene and evidence handling, concepts in genetics, biochemistry, statistics, DNA evidence, and DNA testing. The book will be particularly helpful for forensic science laboratory technicians, police and investigations professionals, forensic serology and DNA analysts, attorneys, and forensic science students. This study guide follows the guidelines for the exam and presents all the information necessary to prepare individuals to pass the exam.
Publisher: CRC Press
ISBN: 1498753930
Category : Law
Languages : en
Pages : 241
Book Description
In 2009, the National Academy of Sciences (NAS) authored the report Strengthening Forensic Science in the United States: A Path Forward. In it, the Committee expressed the need for accreditation and certification. Accreditation, long recognized by public labs as an important benchmark in quality, was recognized as an important way to standardize laboratories that provide forensic services. Certification can play an important role as a method of oversight in the forensic sciences—something also recommended by the - National Commission on Forensic Science in October 2014. The Complete Guide to the ABC's Molecular Biology is a professional certification examination preparation text for forensic scientists taking the American Board of Criminalistics Examination in Molecular Biology. The book serves as a resource for forensic scientists—who are facing more and more pressure to become certified—to support them in their pursuit of forensic certification. In the years since the NAS report was published, there has been increased discussion of forensic certification requirements. ABC’s Molecular Biology exam is a quality certification, and learning the concepts for it will invariably help any professional working in the field. The book prepares readers in all relevant topic areas, including: accreditation, safety, biological screen principles, anatomy and cell biology, crime scene and evidence handling, concepts in genetics, biochemistry, statistics, DNA evidence, and DNA testing. The book will be particularly helpful for forensic science laboratory technicians, police and investigations professionals, forensic serology and DNA analysts, attorneys, and forensic science students. This study guide follows the guidelines for the exam and presents all the information necessary to prepare individuals to pass the exam.
Handbook of Project Management
Author: Colin Dobie
Publisher: Routledge
ISBN: 1000257320
Category : Business & Economics
Languages : en
Pages : 451
Book Description
The practical approach that Colin Dobie prescribes is as applicable to the experienced project manager as it is anyone entering the field.' Ernest J. Nielsen, Brigham Young University, USA A no-nonsense approach to project management. Essential reading for all project managers and project team members.' Peter Dechaineux, Inaugural Chairman, Australian Institute of Project Management, Australia Excellent coverage of all the material required in easy to follow steps. It places activities in logical context. Essential reading for China's many project managers.' Professor Yuan, Chairman, Asia-Pacific Federation of Project Management.' Colin Dobie has very comprehensively detailed out the intricacies needed to manage projects. Well done.' Adesh Jain, President, PM Guru Inc. and President, IPMA Whether you are creating a new product or building a power station, you need to know how to manage the myriad elements in a project to ensure it is completed on time, on budget and to a high standard. A Handbook of Project Management is a practical and comprehensive guide for project managers working on small and large projects in any field. Colin Dobie systematically maps the four phases in the project lifecycle: initiation, planning, implementation and finalisation. He outlines the processes and techniques of the nine functions of project management, and how they are applied during the project lifecycle. He also explains what a project manager is expected to deliver, and the roles of team leaders and team members. Drawing on international standards and bodies of knowledge, as well as Colin Dobie's extensive industry and training experience in several countries, A Handbook of Project Management is an indispensable guide for anyone who wants to develop their skills in project management. It is extensively illustrated with examples, templates, exercises and checklists, making it valuable resource for experienced project managers.
Publisher: Routledge
ISBN: 1000257320
Category : Business & Economics
Languages : en
Pages : 451
Book Description
The practical approach that Colin Dobie prescribes is as applicable to the experienced project manager as it is anyone entering the field.' Ernest J. Nielsen, Brigham Young University, USA A no-nonsense approach to project management. Essential reading for all project managers and project team members.' Peter Dechaineux, Inaugural Chairman, Australian Institute of Project Management, Australia Excellent coverage of all the material required in easy to follow steps. It places activities in logical context. Essential reading for China's many project managers.' Professor Yuan, Chairman, Asia-Pacific Federation of Project Management.' Colin Dobie has very comprehensively detailed out the intricacies needed to manage projects. Well done.' Adesh Jain, President, PM Guru Inc. and President, IPMA Whether you are creating a new product or building a power station, you need to know how to manage the myriad elements in a project to ensure it is completed on time, on budget and to a high standard. A Handbook of Project Management is a practical and comprehensive guide for project managers working on small and large projects in any field. Colin Dobie systematically maps the four phases in the project lifecycle: initiation, planning, implementation and finalisation. He outlines the processes and techniques of the nine functions of project management, and how they are applied during the project lifecycle. He also explains what a project manager is expected to deliver, and the roles of team leaders and team members. Drawing on international standards and bodies of knowledge, as well as Colin Dobie's extensive industry and training experience in several countries, A Handbook of Project Management is an indispensable guide for anyone who wants to develop their skills in project management. It is extensively illustrated with examples, templates, exercises and checklists, making it valuable resource for experienced project managers.
Integrating Business Management Processes
Author: Titus De Silva
Publisher: CRC Press
ISBN: 100009751X
Category : Business & Economics
Languages : en
Pages : 327
Book Description
Integrating Business Management Processes: Volume 2: Support and Assurance Processes (978-0-367-48548-1) Shelving Guide: Business & Management The backbone of any organisation is its management system. It must reflect the needs of the organisation and the requirements of its customers. Compliance with legal requirements and ethical environmental practices contributes towards the sustainability of the management system. Whatever the state of maturity of the management, this book, one of three, provides useful guidance to design, implement, maintain and improve its effectiveness. This volume provides a comprehensive coverage of the key support and assurance processes. Topics include document control, communication, marketing, information systems and technology, human resource management, training and development, customer relations management, financial management and measurement and analysis to name a few. This book, with its series of examples and procedures, shows how organisations can benefit from satisfying customer requirement and the requirements of ISO standards to gain entry into lucrative markets. Titus De Silva is a consultant in management skills development, pharmacy practice, quality management and food safety and an advisor to the newly established National Medicines Regulatory Authority (NMRA) in Sri Lanka.
Publisher: CRC Press
ISBN: 100009751X
Category : Business & Economics
Languages : en
Pages : 327
Book Description
Integrating Business Management Processes: Volume 2: Support and Assurance Processes (978-0-367-48548-1) Shelving Guide: Business & Management The backbone of any organisation is its management system. It must reflect the needs of the organisation and the requirements of its customers. Compliance with legal requirements and ethical environmental practices contributes towards the sustainability of the management system. Whatever the state of maturity of the management, this book, one of three, provides useful guidance to design, implement, maintain and improve its effectiveness. This volume provides a comprehensive coverage of the key support and assurance processes. Topics include document control, communication, marketing, information systems and technology, human resource management, training and development, customer relations management, financial management and measurement and analysis to name a few. This book, with its series of examples and procedures, shows how organisations can benefit from satisfying customer requirement and the requirements of ISO standards to gain entry into lucrative markets. Titus De Silva is a consultant in management skills development, pharmacy practice, quality management and food safety and an advisor to the newly established National Medicines Regulatory Authority (NMRA) in Sri Lanka.
Medical Device Regulations
Author: Aakash Deep
Publisher: Academic Press
ISBN: 0323911277
Category : Technology & Engineering
Languages : en
Pages : 187
Book Description
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Publisher: Academic Press
ISBN: 0323911277
Category : Technology & Engineering
Languages : en
Pages : 187
Book Description
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products