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Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1351000772
Category : Medical
Languages : en
Pages : 735
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Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1351000772
Category : Medical
Languages : en
Pages : 735
Get Book Here
Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: Erik V. Myhrberg
Publisher: Quality Press
ISBN: 1951058216
Category : Business & Economics
Languages : en
Pages : 252
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Book Description
The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS
Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1439866112
Category : Medical
Languages : en
Pages : 376
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Book Description
Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 36
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Book Description
Author: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 1953079504
Category : Business & Economics
Languages : en
Pages : 159
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Book Description
This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
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.
Author: Edward P. Link
Publisher:
ISBN: 9781513616643
Category :
Languages : en
Pages : 141
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Book Description
Author: Jack Wong
Publisher: CRC Press
ISBN: 1000440516
Category : Medical
Languages : en
Pages : 806
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Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author: Steven C. Schachter
Publisher: Cambridge University Press
ISBN: 100939701X
Category : Medical
Languages : en
Pages : 301
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Book Description
By presenting chapter-specific roadmaps, this book offers a behind-the-scenes chronology of the response to COVID-19 and provides a rubric for future pandemic response. Targeted at lay and scientific audiences, reflections and lessons learned grant the reader an opportunity to leverage this knowledge and improve the outcomes of future pandemics.
Author: Alfred Zimmermann
Publisher: Springer Nature
ISBN: 981193455X
Category : Technology & Engineering
Languages : en
Pages : 252
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Book Description
The volume includes papers presented at the International KES Conference on Human Centred Intelligent Systems 2022 (KES HCIS 2022), held in Rhodes, Greece on June 20–22, 2022. This book highlights new trends and challenges in intelligent systems, which play an important part in the digital transformation of many areas of science and practice. It includes papers offering a deeper understanding of the human-centred perspective on artificial intelligence, of intelligent value co-creation, ethics, value-oriented digital models, transparency, and intelligent digital architectures and engineering to support digital services and intelligent systems, the transformation of structures in digital businesses and intelligent systems based on human practices, as well as the study of interaction and the co-adaptation of humans and systems.
