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.
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
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:
Download or read book A Practical Field Guide for ISO 13485 written by Erik V. Myhrberg and published by ASQ Quality Press. This book was released on 2019-11-06 with total page 0 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
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.
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.
Download or read book Medical Devices written by International Organization for Standardization and published by . This book was released on 2003 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidance on the Relationship Between en ISO 13485 written by British Standards Institute Staff and published by . This book was released on 1918-03-21 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Management, Diagnostic equipment (medical), Quality management, Medical equipment, Information management
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.
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.
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.
Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Proactive Supplier Management in the Medical Device Industry written by James B. Shore and published by Quality Press. This book was released on 2016-05-06 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether its a requirement or a tool to help achieve compliance. The Lessons from the Road icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
Download or read book ISO 13485 for Engineers written by Priscilla Browne and published by Independently Published. This book was released on 2021-12 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is written to provide Quality engineers, medical engineers, device engineers with a practical and insightful companion to understand ISO 13485, Quality Management system for medical devices. It provides a straight-to-the-point perspective which should assist in the interpretation of the standard and provide a benchmark for what is expected in the application of the standard and compliance for industry. ISO 13485:2016 is an international standard for the quality management of medical devices. It is of value and applicable to a number of business areas that are involved in the various stages of a medical device and its product lifecycle. It may be applied by a design company, manufacturer, raw material supplier, calibration service, sterilization services or distributer. The scope of the standard covers: design and development production, storage and distribution installation servicing (if required) decommissioning and disposal In particular, manufacturers of medical devices and typically mandated by regulatory bodies to comply with ISO 13484, and must demonstrate compliance and application of the standard subject to certification and an audit process. FDA, 21 CFR Part 820 is another example of a Quality Management system. While its official designation is a Quality System (QS) it serves a similar purpose to ISO 13485- Quality management system for medical devices. However, there is an important distinction. 21 CFR Part 820 has a regulatory standing in the United states. While many competent authorities require the application of ISO 13485, the framework of ISO 13485 is a standard opposed to a regulation. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organisation 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 organisation or company involved 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. The 2016 revision is designed to address recent developments in quality management and other updated regulations that relate to the industry. Improvements in the new version of the standard include broadening its applicability to include all organisations involved in the life cycle of the product, from the concept stage to end of life along with greater alignment with regulatory requirements and post-market surveillance including complaint handling. Overview of Content: Introduction to ISO 13485, Directives and Standards, Competent Authorities, Notified Bodies, How ISO 13485 differs to ISO 900I ISO/TR 14969, Terms /Definitions, Process Approach, Plan-Do-Check-Act (PDCA) Quality Management System, Introduction, Regulatory Requirements, Risk Based Approach, Changes within the QMS, Documentation, Quality Manual, Control of Records Management Responsibility, Management Commitment, Customer Focus, Quality Policy, Planning, Management Review, Resource Management, Provision of resources, Human resources, Infrastructure, Work environment & contamination control, Product realization, Planning of Product Realization, Design and Development, Production and service provision, Ctrl of monitoring & measuring equipment Measurement Analysis PART 2 Good Documentation Practices, Introduction, Quality Management Systems PART 3 Validation Introduction, Equipment and Software Validation, Software Validation, Process Validation, Packaging Validation
Download or read book Medical Devices Quality Management Systems Requirements for Regulatory Purposes written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 2003-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
