Developing An Iso 13485 Certified Quality Management System

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Developing an ISO 13485-Certified Quality Management System

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000550680
Total Pages : 331 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso

Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.

ISO 13485:2016

Author : Itay Abuhav
Publisher : CRC Press
ISBN 13 : 1351000772
Total Pages : 735 pages
Book Rating : 4.3/5 (51 download)

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Book Synopsis ISO 13485:2016 by : Itay Abuhav

Download or read book ISO 13485:2016 written by Itay Abuhav and published by CRC Press. This book was released on 2018-05-11 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Developing an ISO 13485-Certified Quality Management System

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000550664
Total Pages : 371 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso

Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.

A Practical Field Guide for ISO 13485:2016

Author : Erik V. Myhrberg
Publisher : Quality Press
ISBN 13 : 1951058216
Total Pages : 252 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis A Practical Field Guide for ISO 13485:2016 by : Erik V. Myhrberg

Download or read book A Practical Field Guide for ISO 13485:2016 written by Erik V. Myhrberg and published by Quality Press. This book was released on 2019-11-06 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

ISO 13485

Author : Itay Abuhav
Publisher : CRC Press
ISBN 13 : 1439866112
Total Pages : 376 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis ISO 13485 by : Itay Abuhav

Download or read book ISO 13485 written by Itay Abuhav and published by CRC Press. This book was released on 2011-10-20 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Achieving Customer Experience Excellence through a Quality Management System

Author : Alka Jarvis
Publisher : Quality Press
ISBN 13 : 0873899350
Total Pages : 245 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Achieving Customer Experience Excellence through a Quality Management System by : Alka Jarvis

Download or read book Achieving Customer Experience Excellence through a Quality Management System written by Alka Jarvis and published by Quality Press. This book was released on 2016-07-08 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are in what many call The Age of the Customer. Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements

Author : Stephanie L. Skipper
Publisher : Quality Press
ISBN 13 : 1953079504
Total Pages : 159 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements by : Stephanie L. Skipper

Download or read book How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements written by Stephanie L. Skipper and published by Quality Press. This book was released on 2015-10-12 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

ISO 9001:2000 Quality Management System Design

Author : Jay J. Schlickman
Publisher : Artech House
ISBN 13 : 9781580535960
Total Pages : 408 pages
Book Rating : 4.5/5 (359 download)

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Book Synopsis ISO 9001:2000 Quality Management System Design by : Jay J. Schlickman

Download or read book ISO 9001:2000 Quality Management System Design written by Jay J. Schlickman and published by Artech House. This book was released on 2003 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system."--Jacket.

Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation

Download Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation PDF Online Free

Author : Martin Mach
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation by : Martin Mach

Download or read book Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation written by Martin Mach and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: CDG Biotech Corporation, a new biotechnology startup, plans to introduce medical devices for use in immunological diagnostics and therapies. CDG seeks to develop and implement a quality manual as part of their quality management system and to gain accreditation approval domestically and internationally. This project attempts to develop a customized quality manual based on International Organization for Standardization (ISO 13485:2016) standards utilizing quality management and technical project management concepts and tools. The main goal of the project is to provide a quality manual for medical devices with an emphasis on section 4: Quality Management System and section 5: Management Responsibility of the ISO standard. The quality manual and the quality management and project management tools/concepts provide a basic framework of the broader quality management system. The level of detail, depth, and outcome is limited by the time, cost, and external factors of business, regulatory, and international factors.

Implement ISO9001:2008 Quality Management System

Author : DIVYA SINGHAL
Publisher : PHI Learning Pvt. Ltd.
ISBN 13 : 8120345746
Total Pages : 199 pages
Book Rating : 4.1/5 (23 download)

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Book Synopsis Implement ISO9001:2008 Quality Management System by : DIVYA SINGHAL

Download or read book Implement ISO9001:2008 Quality Management System written by DIVYA SINGHAL and published by PHI Learning Pvt. Ltd.. This book was released on 2012-04-02 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9000 series standards have changed the whole concept of quality management methods. ISO 9001:2008 QMS standard has been implemented and ISO 9000 series standards have been adopted as national standards or endorsed for use in 178 countries and economies. ISO 9001:2008 Quality Management System (QMS) is based on eight quality management principles and there are various internal and external benefits of implementing this standard, whether or not an organization goes for certification. This book provides the readers with an accessible and up-to-date introduction to the essentials of a quality management system, discusses what is in the ISO 9001:2008 QMS and shows how the organizations can implement this system. With the authors’ extensive experience in QMS audit, training and advisory services, the book incorporates basic information on understanding and implementing ISO 9001:2008 QMS and highlights its importance towards making quality the fundamental business principle. The text contains plenty of practical tips and guidance on how to implement ISO 9001:2008 QMS in the real world. It discusses sample QMS procedures, emphasizes the importance of maintaining a value added internal audit system and highlights the necessity of developing the QMS documentation procedures. Apart from the regular BBA, MBA, and diploma courses in Total Quality Management, this book is also suitable for Management Development Programmes in Quality Management and ISO 9001 offered to professionals by many of the B-schools.

Medical-Grade Software Development

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000987906
Total Pages : 256 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Medical-Grade Software Development by : Ilkka Juuso

Download or read book Medical-Grade Software Development written by Ilkka Juuso and published by CRC Press. This book was released on 2023-11-13 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.

Laboratory Quality Management System

Author : World Health Organization
Publisher :
ISBN 13 : 9789241548274
Total Pages : 0 pages
Book Rating : 4.5/5 (482 download)

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Book Synopsis Laboratory Quality Management System by : World Health Organization

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".

ISO 13485 Quality Management System A Complete Guide - 2020 Edition

Author : Gerardus Blokdyk
Publisher : 5starcooks
ISBN 13 : 9780655926351
Total Pages : 308 pages
Book Rating : 4.9/5 (263 download)

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Book Synopsis ISO 13485 Quality Management System A Complete Guide - 2020 Edition by : Gerardus Blokdyk

Download or read book ISO 13485 Quality Management System A Complete Guide - 2020 Edition written by Gerardus Blokdyk and published by 5starcooks. This book was released on 2019-09-23 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: What will employees need to do for the ISO 13485 Quality Management System? What is the rationale for this approach? Why is your organizational structure important for you to understand? How are regulatory requirements met? How can you handle a nonconformity before it occurs? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make ISO 13485 Quality Management System investments work better. This ISO 13485 Quality Management System All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth ISO 13485 Quality Management System Self-Assessment. Featuring 957 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which ISO 13485 Quality Management System improvements can be made. In using the questions you will be better able to: - diagnose ISO 13485 Quality Management System projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in ISO 13485 Quality Management System and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the ISO 13485 Quality Management System Scorecard, you will develop a clear picture of which ISO 13485 Quality Management System areas need attention. Your purchase includes access details to the ISO 13485 Quality Management System self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific ISO 13485 Quality Management System Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author : Amiram Daniel
Publisher : Quality Press
ISBN 13 : 0873897404
Total Pages : 355 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel

Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Design Controls for the Medical Device Industry

Author : Marie Teixeira
Publisher : CRC Press
ISBN 13 : 9780203909386
Total Pages : 258 pages
Book Rating : 4.9/5 (93 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Service Design for Emerging Technologies Product Development

Author : Umar Zakir Abdul Hamid
Publisher : Springer Nature
ISBN 13 : 3031293061
Total Pages : 336 pages
Book Rating : 4.0/5 (312 download)

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Book Synopsis Service Design for Emerging Technologies Product Development by : Umar Zakir Abdul Hamid

Download or read book Service Design for Emerging Technologies Product Development written by Umar Zakir Abdul Hamid and published by Springer Nature. This book was released on 2023-07-20 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: The productization of emerging technologies related to the Fourth Industrial Revolution (FIR) is now getting more attention across different industries. Compared to the previous industrial transformations that the world has seen which relied on mechanical innovations, the ongoing FIR is seeing software and data-driven products as the foundation. Apart from that, topics such as circular and sustainable economy as well as climate change are also disrupting the industrial ecosystem. For a viable and successful productization of emerging technologies, collaborations between interdisciplinary stakeholders are a necessity. One of the elements that has been identified to facilitate this collaboration is service design. This book aimed to provide comprehensive service design discussions for practitioners in different fields and sectors. The aim is to bridge the knowledge gap between experts in academia, business and product development, among many others, to provide a unified understanding of the importance of service design for the productization of emerging technologies. The book consists of an overview of emerging technologies product development and service design, as well as perspectives from different sectors of the industry. The book is expected to benefit multi-disciplinary researchers, practitioners and general audiences with interests in Service Design for Emerging Technologies.

Medical Device Regulations

Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Device Regulations by : Michael Cheng

Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.