Medical Device Quality Management Systems

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

Produk Detail:

  • Author : Susanne Manz
  • Publisher : Academic Press
  • Pages : 294 pages
  • ISBN : 0128142227
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKMedical Device Quality Management Systems

Medical Device Quality Management Systems

Medical Device Quality Management Systems
  • Author : Susanne Manz
  • Publisher : Academic Press
  • Release : 27 September 2018
GET THIS BOOKMedical Device Quality Management Systems

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

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
  • Release : 01 January 2008
GET THIS BOOKThe FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

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

A Practical Field Guide For ISO 13485:2016

A Practical Field Guide For ISO 13485:2016
  • Author : Erik V. Myhrberg,Joseph Raciti,Brandon L. Myhrberg
  • Publisher : Quality Press
  • Release : 06 November 2019
GET THIS BOOKA Practical Field Guide For ISO 13485:2016

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

ISO 13485:2016

ISO 13485:2016
  • Author : Itay Abuhav
  • Publisher : CRC Press
  • Release : 11 May 2018
GET THIS BOOKISO 13485:2016

This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises

Proactive Supplier Management in the Medical Device Industry

Proactive Supplier Management in the Medical Device Industry
  • Author : James B. Shore,John A. Freije
  • Publisher : Quality Press
  • Release : 06 May 2016
GET THIS BOOKProactive Supplier Management in the Medical Device Industry

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

ISO 13485

ISO 13485
  • Author : Itay Abuhav
  • Publisher : CRC Press
  • Release : 20 October 2011
GET THIS BOOKISO 13485

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

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release : 18 August 2015
GET THIS BOOKMedical Devices

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

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 29 June 2018
GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk

Medical Device Software Verification, Validation and Compliance

Medical Device Software Verification, Validation and Compliance
  • Author : David A. Vogel
  • Publisher : Artech House
  • Release : 13 April 2021
GET THIS BOOKMedical Device Software Verification, Validation and Compliance

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:

Plastics in Medical Devices

Plastics in Medical Devices
  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release : 05 March 2010
GET THIS BOOKPlastics in Medical Devices

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the

Safe and Sound Software

Safe and Sound Software
  • Author : Thomas H. Faris
  • Publisher : Asq Press
  • Release : 13 April 2021
GET THIS BOOKSafe and Sound Software

"This book provides information and recommendations to help regulatory affairs and quality managers, and consultants of software medical device design and development organizations, navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system. Software organization executives, functional managers, and other interested coworkers can also use this book to secure a general understanding of the subject matter."--BOOK JACKET.

ANSI/AAMI SW87:2012 Application of Quality Management System Concepts to Medical Device Data Systems

ANSI/AAMI SW87:2012 Application of Quality Management System Concepts to Medical Device Data Systems
  • Author : Association for the Advancement of Medical Instrumentation. Medical Device Data Systems Working Group,Association for the Advancement of Medical Instrumentation,Association for the Advancement of Medical Instrumentation. Medical Device Software Committee,American National Standards Institute
  • Publisher : Unknown Publisher
  • Release : 13 April 2021
GET THIS BOOKANSI/AAMI SW87:2012 Application of Quality Management System Concepts to Medical Device Data Systems

This recommended practice provides information that will allow the medical device data system manufacturer to implement a quality management system that is commensurate with the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization.

Medical Device Technologies

Medical Device Technologies
  • Author : Gail D. Baura
  • Publisher : Academic Press
  • Release : 13 April 2021
GET THIS BOOKMedical Device Technologies

The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
  • Author : Orlando Lopez
  • Publisher : Taylor & Francis
  • Release : 02 October 2018
GET THIS BOOKPharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of