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Iso 13485 Starter Guide
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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 Productivity Press. This book was released on 2022-03-21 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book 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.
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.
Book Synopsis ISO 13485 Starter Guide by : Emmet Tobin
Download or read book ISO 13485 Starter Guide written by Emmet Tobin and published by Createspace Independent Publishing Platform. This book was released on 2016-06-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised in 2021, This short, concise book provides an introduction to ISO 13485. It is written in accessible language, providing a straight forward resource for the reader. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements." The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services.(Page count pages 82) While not suitable for experienced or advanced professionals, this publication aims to provide context and a fundamental grounding in ISO 13486- Quality management system for medical devices. Second Edition, 2021
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
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 338 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.
Book Synopsis Medical Device Regulations Roadmap by : Des O'Brien
Download or read book Medical Device Regulations Roadmap written by Des O'Brien and published by Createspace Independent Publishing Platform. This book was released on 2017-10-11 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies also need to fulfill regulation from multiple jurisdictions. Some requirements of Design, GMP and manufacturing are common. FDA and European market requires provide a framework for medical device manufacturers to certain requirements that ensure patient safety. This short book introduces the key themes associated with Medical Device Regulation. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction and provides in a physical format that is a useful companion for the Engineer or Medical Device Professional. (Page Count 112)
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.
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.
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
Book Synopsis An Audit of the System, Not of the People by : Edward P. Link
Download or read book An Audit of the System, Not of the People written by Edward P. Link and published by . This book was released on 2016-11-01 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis ISO 13485-2016. Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes by :
Download or read book ISO 13485-2016. Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes written by and published by . This book was released on 2016 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Evaluation of Medical Devices by : Karen M. Becker
Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Book Synopsis Biomedical Equipment Technician - The Comprehensive Guide by : VIRUTI SHIVAN
Download or read book Biomedical Equipment Technician - The Comprehensive Guide written by VIRUTI SHIVAN and published by Viruti Satyan Shivan. This book was released on with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dive into the critical world of biomedical equipment technology, where precision meets care in "Biomedical Equipment Technician: The Comprehensive Guide." This essential volume offers an unparalleled exploration of the devices that are the heartbeat of modern medical facilities, from life-saving diagnostic machines to the complex systems that support day-to-day healthcare operations. Without relying on images or illustrations to guide you—for copyright reasons—this guide stands out by delivering in-depth knowledge through vivid descriptions, engaging examples, and clear, straightforward explanations. It's designed to equip aspiring technicians, seasoned professionals, and healthcare stakeholders with the technical prowess and critical thinking skills needed to excel in this rapidly evolving field. In a landscape where technological advancements continuously reshape healthcare delivery, this book emerges as a beacon for those committed to maintaining the lifeline of medical equipment. It delves into the nuances of equipment operation, maintenance, troubleshooting, and innovation with a keen eye on the future of healthcare technologies. By weaving together theoretical insights, regulatory frameworks, and practical strategies for effective equipment management, the guide promises to not only enhance your skillset but also to inspire a deeper appreciation for the role of technology in healthcare. Embrace the opportunity to become a pivotal part of healthcare's success, armed with knowledge and insights found nowhere else.
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.
Book Synopsis A guide to create "Secure" throughout the supply chain, from design to maintenance. by : Hiroyuki Watanabe
Download or read book A guide to create "Secure" throughout the supply chain, from design to maintenance. written by Hiroyuki Watanabe and published by Ohmsha, Ltd.. This book was released on 2023-03-31 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: Secure production throughout the supply chain, from development to production to maintenance Cyber-attacks targeting the manufacturing industry are on the rise, and combined with the advancement of digital transformation, security measures throughout the supply chain have become an urgent need. In the complex interconnected supply network, it is essential to understand the differences between your company's business model and that of its partners, and to promote your company's security reforms while understanding the differences. This book introduces know-how as a guide. Since it is not a good idea to aim for perfection right off the bat, the book is structured in such a way that you can move forward by taking concrete action, starting with the chapter "Get the job done quickly" which explains in an easy-to-understand manner methods that will have an immediate effect considering your position when you are assigned to carry out reforms. Detailed explanations that answer questions such as more details and why are provided in the latter half of the book. The authors have also prepared a list of "Several mistakes that should not be made" based on their own experiences. We hope that anyone who has been ordered to take security measures for their own company, factory, or department, or who has been assigned to security consulting work without field experience, will pick up this book and use it as a manual for quick, in-depth, and situation-specific understanding and reference. We hope that this several-thousand-yen book will be worth as much as a several-million-yen consulting assignment for you in the field of reform, and tens of millions of yen for you as a consultant with little field experience. Upon Publication Section 1 Security is Important, Says the Boss Section 2 Get the job done quickly Section 3 The Partner on the supply network Section 4 Cutting corners is fatal in Operations Section 5 The Basics (read when you face difficulties) Section 6 Practical Application: Creating a Factory-Based Security Organization Section 7 How to proceed with factory security measures Section 8 Several mistakes that should not be made Section 9 Related Information Glossary
Book Synopsis Medical Regulatory Affairs by : Jack Wong
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King
Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
