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Medical Device Quality Management Systems

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Medical Device Quality Management Systems

Medical Device Quality Management Systems Book
Author : Susanne Manz
Publisher : Academic Press
Release : 2018-09-27
ISBN : 0128142227
Language : En, Es, Fr & De

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Book Description :

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

ISO 13485

ISO 13485 Book
Author : Itay Abuhav
Publisher : CRC Press
Release : 2011-10-20
ISBN : 1439866112
Language : En, Es, Fr & De

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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 Devices

Medical Devices Book
Author : International Organization for Standardization
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by International Organization for Standardization, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Devices

Medical Devices Book
Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Release : 2015-08-18
ISBN : 0081002912
Language : En, Es, Fr & De

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Book Description :

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Medical Device Use Error

Medical Device Use Error Book
Author : Michael Wiklund,Andrea Dwyer,Erin Davis
Publisher : CRC Press
Release : 2016-01-06
ISBN : 1498705804
Language : En, Es, Fr & De

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Book Description :

Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors

Plastics in Medical Devices

Plastics in Medical Devices Book
Author : Vinny R. Sastri
Publisher : William Andrew
Release : 2021-10-01
ISBN : 0323851274
Language : En, Es, Fr & De

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Book Description :

Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management Supports the development, marketing and commercialization of medical devices and materials for use in medical devices

Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 1998-08-11
ISBN : 9780824701772
Language : En, Es, Fr & De

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Book Description :

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

The ASQ Certified Medical Device Auditor Handbook Fourth Edition

The ASQ Certified Medical Device Auditor Handbook  Fourth Edition Book
Author : Scott A Laman
Publisher : Quality Press
Release : 2021-02-05
ISBN : 1953079970
Language : En, Es, Fr & De

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Book Description :

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques

ISO 9001 2000 Quality Management System Design

ISO 9001 2000 Quality Management System Design Book
Author : Jay J. Schlickman
Publisher : Artech House
Release : 2003
ISBN : 9781580535960
Language : En, Es, Fr & De

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Book Description :

"The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system."--Jacket.

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma Book
Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210417
Language : En, Es, Fr & De

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Book Description :

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Designing A World Class Quality Management System For FDA Regulated Industries

Designing A World Class Quality Management System For FDA Regulated Industries Book
Author : David N. Muchemu
Publisher : AuthorHouse
Release : 2008-04-07
ISBN : 1468522728
Language : En, Es, Fr & De

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Book Description :

Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the following for you: 1.It helps Managers in Startup companies design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device,Pharmaceutical,Tissue,and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485,and ISO 9001 5.It provides standard definitions for the Quality management system 6.It provides examples of Quality system related warning letters written by the FDA during onsite audits 7.It provides the reader several models of a Quality Management system

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia Book
Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Release : 2018-03-28
ISBN : 0429996772
Language : En, Es, Fr & De

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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. 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.

Medical Device Software Verification Validation and Compliance

Medical Device Software Verification  Validation and Compliance Book
Author : David A. Vogel
Publisher : Artech House
Release : 2010
ISBN : 1596934239
Language : En, Es, Fr & De

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Book Description :

HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

Healthcare Technology Management A Systematic Approach

Healthcare Technology Management     A Systematic Approach Book
Author : Francis Hegarty,John Amoore,Paul Blackett,Justin McCarthy,Richard Scott
Publisher : CRC Press
Release : 2017-01-06
ISBN : 1315354500
Language : En, Es, Fr & De

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Book Description :

Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit: www.htmbook.com

Medical Device Design and Regulation

Medical Device Design and Regulation Book
Author : Carl T. DeMarco
Publisher : Quality Press
Release : 2011-01-01
ISBN : 0873898168
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Design and Regulation book written by Carl T. DeMarco, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmaceutical Care in Digital Revolution

Pharmaceutical Care in Digital Revolution Book
Author : Claudia Rijcken
Publisher : Academic Press
Release : 2019-03-15
ISBN : 0128176393
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Care in Digital Revolution demonstrates how blending human and digital pharmaceutical care can establish optimal Apothecary Intelligence (AI). Organized into four parts, it examines digital health advances that will synergize the pharmaceutical care process and prepares stakeholders for a dynamic future, fueled with innovation. Beginning with the global picture on health care systems, patients’ expectations, and current pharmaceutical care practices, the book covers details of relevant digital technologies as well as compliance, ethical, educational, and cultural aspects to take successful steps towards digital pharmaceutical care. The text includes links to lectures and technology facts, tutorials on how to implement advances in your own working environment, and examples of stakeholders who are successful in building synergy between digital and pharma. Pharmaceutical Care in Digital Revolution is a practical resource to equip pharmaceutical care stakeholders, such as pharmacists, physicians, pharmacy technicians, and students as well as those in surrounding ecosystems like payers or regulators. It is a crucial reference to understand how technological innovation is changing the paradigm in which we provide current and future pharmaceutical care and how to keep it accessible, affordable, and sustainable. Learn about advances in digital health technology and apply them as a change leader to create circular pharmaceutical care Provides insights on future pharmaceutical care and implement essential conditions to create the best outlook for patients Access links, QR codes, and explanatory animations as educational material to the book

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book
Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Release : 2003-09-02
ISBN : 9780203305195
Language : En, Es, Fr & De

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Book Description :

Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Design Controls for the Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition Book
Author : Marie B. Teixeira
Publisher : CRC Press
Release : 2013-11-12
ISBN : 1466503556
Language : En, Es, Fr & De

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Book Description :

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Biomedical Devices

Biomedical Devices Book
Author : Tŭgrul ?zel,Paolo Jorge B?rtolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Release : 2016-10-24
ISBN : 1118478924
Language : En, Es, Fr & De

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Book Description :

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source