A Practical Field Guide for ISO 13485:2016 PDF Download

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: 9781032240428
Category :
Languages : en
Pages : 444

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Book Description
This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in th

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: Jack Wong
Publisher: CRC Press
ISBN: 9814411213
Category : Medical
Languages : en
Pages : 618

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Book Description
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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Author: Marie Teixeira
Publisher: CRC Press
ISBN: 9780203909386
Category : Medical
Languages : en
Pages : 258

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Book Description
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

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: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0

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Book Description

Author: Aakash Deep
Publisher: Academic Press
ISBN: 0323911277
Category : Technology & Engineering
Languages : en
Pages : 187

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Book Description
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Author: Thomas Wischmeyer
Publisher: Springer Nature
ISBN: 3030323617
Category : Law
Languages : en
Pages : 391

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Book Description
This book assesses the normative and practical challenges for artificial intelligence (AI) regulation, offers comprehensive information on the laws that currently shape or restrict the design or use of AI, and develops policy recommendations for those areas in which regulation is most urgently needed. By gathering contributions from scholars who are experts in their respective fields of legal research, it demonstrates that AI regulation is not a specialized sub-discipline, but affects the entire legal system and thus concerns all lawyers. Machine learning-based technology, which lies at the heart of what is commonly referred to as AI, is increasingly being employed to make policy and business decisions with broad social impacts, and therefore runs the risk of causing wide-scale damage. At the same time, AI technology is becoming more and more complex and difficult to understand, making it harder to determine whether or not it is being used in accordance with the law. In light of this situation, even tech enthusiasts are calling for stricter regulation of AI. Legislators, too, are stepping in and have begun to pass AI laws, including the prohibition of automated decision-making systems in Article 22 of the General Data Protection Regulation, the New York City AI transparency bill, and the 2017 amendments to the German Cartel Act and German Administrative Procedure Act. While the belief that something needs to be done is widely shared, there is far less clarity about what exactly can or should be done, or what effective regulation might look like. The book is divided into two major parts, the first of which focuses on features common to most AI systems, and explores how they relate to the legal framework for data-driven technologies, which already exists in the form of (national and supra-national) constitutional law, EU data protection and competition law, and anti-discrimination law. In the second part, the book examines in detail a number of relevant sectors in which AI is increasingly shaping decision-making processes, ranging from the notorious social media and the legal, financial and healthcare industries, to fields like law enforcement and tax law, in which we can observe how regulation by AI is becoming a reality.

Author: Ilkka Juuso
Publisher: CRC Press
ISBN: 1000550680
Category : Business & Economics
Languages : en
Pages : 331

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Book Description
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.