A Practical Field Guide for ISO 13485:2016
A Practical Field Guide for ISO 13485:2016

Author: Erik V. Myhrberg

Publisher: Quality Press

Published: 2019-11-06

Total Pages: 252

ISBN-13: 1951058216

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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

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel

Publisher: Quality Press

Published: 2008-01-01

Total Pages: 338

ISBN-13: 0873897404

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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.

ISO 13485
ISO 13485

Author: Itay Abuhav

Publisher: CRC Press

Published: 2011-10-20

Total Pages: 376

ISBN-13: 1439866112

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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.

A Practical Guide to Decontamination in Healthcare
A Practical Guide to Decontamination in Healthcare

Author: Gerald E. McDonnell

Publisher: John Wiley & Sons

Published: 2012-07-23

Total Pages: 466

ISBN-13: 1444330136

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Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel

Publisher: Quality Press

Published: 2008-02-21

Total Pages: 344

ISBN-13: 0873892046

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This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

A Complete Guide to Maggot Therapy
A Complete Guide to Maggot Therapy

Author: Frank Stadler

Publisher: Open Book Publishers

Published: 2022-07-20

Total Pages: 263

ISBN-13: 180064731X

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Since the revival of maggot therapy in Western wound care approximately thirty years ago, there has been no comprehensive synthesis of what is known about its clinical practice, supply chain management, and social dimensions. This edited volume fills the information vacuum and, importantly, makes the current state of knowledge freely accessible. It is the first to provide sound, evidence-based information and guidance covering the entire supply chain from production to treatment. The chapters are arranged in five parts presenting the latest on clinical practice, the principles of therapeutic action, medicinal maggot production, distribution logistics, and the ethical dimensions of maggot therapy. The contributors have paid particular attention to the challenges encountered in compromised, low-resource healthcare settings such as disasters, conflict, and poverty. There are still many barriers to the widespread uptake of maggot therapy in healthcare settings. This book will be essential reading for a global audience of doctors, nurses, allied healthcare providers, students, and entrepreneurs with an interest in maggot-assisted wound care. It will be the go-to reference for those who plan, regulate, and coordinate healthcare, and want to establish a maggot therapy program, particularly in low- and middle-income and other compromised healthcare settings where maggot therapy can provide much-needed, affordable, and efficacious wound care.

ISO 13485:2016
ISO 13485:2016

Author: Itay Abuhav

Publisher: CRC Press

Published: 2018-05-11

Total Pages: 735

ISBN-13: 1351000772

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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.

Handbook of Medical Device Regulatory Affairs in Asia
Handbook of Medical Device Regulatory Affairs in Asia

Author: Jack Wong

Publisher: CRC Press

Published: 2018-03-28

Total Pages: 475

ISBN-13: 0429996764

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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.

Implementing ISO/IEC 17025:2005
Implementing ISO/IEC 17025:2005

Author: Bhavan "Bob" Mehta

Publisher: Quality Press

Published: 2013-04-16

Total Pages: 225

ISBN-13: 0873898540

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The purpose of this book is to demystify the requirements delineated within ISO/IEC 17025:2005 while providing a road map for organizations that wish to receive/maintain accreditation for their laboratories. AS9100, ISO 9001, and ISO 13485 are standards that support the development and implementation of effective approaches to quality management and are recognized blueprints for the establishment of a quality management system (QMS) for diverse industries. Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique purpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification to ISO 9001 and ISO/IEC 17025.