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ISO 13485:2016

Author : Itay Abuhav

Publisher : CRC Press

Page : 735 pages

File Size : 43,62 MB

Release : 2018-05-11

Category : Medical

ISBN : 1351000772

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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.



Design Controls for the Medical Device Industry

Author : Marie Teixeira

Publisher : CRC Press

Page : 258 pages

File Size : 19,28 MB

Release : 2002-09-20

Category : Medical

ISBN : 9780203909386

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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



ISO 9001

Author : Itay Abuhav

Publisher : CRC Press

Page : 444 pages

File Size : 48,35 MB

Release : 2021-12-13

Category :

ISBN : 9781032240428

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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



ISO 13485

Author : Itay Abuhav

Publisher : CRC Press

Page : 376 pages

File Size : 42,35 MB

Release : 2011-10-20

Category : Medical

ISBN : 1439866112

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Book Description

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.



Medical Device Regulations

Author : Aakash Deep

Publisher : Academic Press

Page : 187 pages

File Size : 18,35 MB

Release : 2022-01-13

Category : Technology & Engineering

ISBN : 0323911277

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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



Medical Device Regulations

Author : Michael Cheng

Publisher : World Health Organization

Page : 54 pages

File Size : 40,61 MB

Release : 2003-09-16

Category : Medical

ISBN : 9241546182

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Book Description

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.





The Complete Guide to Business Risk Management

Author : Kit Sadgrove

Publisher : Routledge

Page : 774 pages

File Size : 44,71 MB

Release : 2020-07-26

Category : Business & Economics

ISBN : 1000152065

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Book Description

Risk management and contingency planning has really come to the fore since the first edition of this book was originally published. Computer failure, fire, fraud, robbery, accident, environmental damage, new regulations - business is constantly under threat. But how do you determine which are the most important dangers for your business? What can you do to lessen the chances of their happening - and minimize the impact if they do happen? In this comprehensive volume Kit Sadgrove shows how you can identify - and control - the relevant threats and ensure that your company will survive. He begins by asking 'What is risk?', 'How do we assess it?' and 'How can it be managed?' He goes on to examine in detail the key danger areas including finance, product quality, health and safety, security and the environment. With case studies, self-assessment exercises and checklists, each chapter looks systematically at what is involved and enables you to draw up action plans that could, for example, provide a defence in law or reduce your insurance premium. The new edition reflects the changes in the global environment, the new risks that have emerged and the effect of macroeconomic factors on business profitability and success. The author has also included a set of case studies to illustrate his ideas in practice.



A Practical Field Guide for ISO 13485:2016

Author : Erik V. Myhrberg

Publisher : Quality Press

Page : 252 pages

File Size : 30,29 MB

Release : 2019-11-06

Category : Business & Economics

ISBN : 1951058216

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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