Design Controls for the Medical Device Industry PDF Download

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: Vernon Geckler
Publisher: Wasatch Consulting Resources LLC
ISBN: 0692835415
Category :
Languages : en
Pages : 441

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Book Description
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Author: Chong Ee
Publisher: IT Governance Publishing
ISBN: 184928296X
Category : Auditing, Internal
Languages : en
Pages : 230

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Book Description
In Compliance by Design, Chong Ee will show you how your organisation can benefit from becoming compliant with the relevant national and international standards. You will discover how integrating controls into your processes will improve your security, increase your productivity, save you time and money, and increase your profits.

Author: Wayne Seames
Publisher: CRC Press
ISBN: 1351784471
Category : Science
Languages : en
Pages : 433

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Book Description
Offering a modern, process-oriented approach emphasizing process control scheme development instead of extended coverage of LaPlace space descriptions of process dynamics, this text focuses on aspects that are most important for process engineering in the 21st century. Instead of starting with the controller, the book starts with the process and moves on to how basic regulatory control schemes can be designed to achieve the process’ objectives while maintaining stable operations. In addition to continuous control concepts, process and control system dynamics are embedded into the text with each new concept presented. The book also includes sections on batch and semi-batch processes and safety automation within each concept area. It discusses the four most common process control loops—feedback, feedforward, ratio, and cascade—and discusses application of these techniques for process control schemes for the most common types of unit operations. It also discusses more advanced and less commonly used regulatory control options such as override, allocation, and split range controllers, includes an introduction to higher level automation functions, and provides guidance for ways to increase the overall safety, stability, and efficiency for many process applications. It introduces the theory behind the most common types of controllers used in the process industries and also provides various additional plant automation-related subjects.

Author: George Ellis
Publisher: Butterworth-Heinemann
ISBN: 0123859204
Category : Technology & Engineering
Languages : en
Pages : 521

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Book Description
This title will help engineers to apply control theory to practical systems using their PC. It provides an intuitive approach to controls, avoiding unecessary math and emphasising key concepts with control system models

Author: United States Government Accountability Office
Publisher: Lulu.com
ISBN: 0359541828
Category : Reference
Languages : en
Pages : 88

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Book Description
Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers? Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.

Author: Jasmijn Bol
Publisher: Business Expert Press
ISBN: 1637420137
Category : Business & Economics
Languages : en
Pages : 204

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Book Description
To remain viable, let alone competitive, organizations must manage risks. In this book, we explore the concept of operational risk as well as the mechanisms used to diminish the impact and occurrence of risks: the organizational control system. Since the scope and scale of operational risks are unique to each organization, our objective is to explain the theory behind why and how managers respond to the unique combination of threats that challenge their organization. We emphasize employee management and the complexities surrounding the design of management controls, incentive systems in particular, because risks related to employee actions are faced by virtually every organization. Overall, we provide empirically grounded insights into the process of diagnosing operational risks as well as designing, implementing and maintaining a control system that properly manages those risks.

Author: Lynford Graham
Publisher: John Wiley & Sons
ISBN: 0470184442
Category : Business & Economics
Languages : en
Pages : 256

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Book Description
"In the new age of philanthropy, donors expect charities to be models of accountability and transparency...Internal controls: Guidance for Private, Government, and Nonprofit Entities is a must read for CEOs and CFOs who want to gain a clear understanding of cost-effective ways to implement the controls necessary to protect their organizations." - Elizabeth Myatt, Chief Executive Officer, World Lung Foundation "If you were looking for the silver bullet to understand and audit internal controls, you just found it. This book will prove invaluable in planning the audit internal controls, you just found it. This book will prove invaluable in planning the audit because it specifically covers COSO and the new AICPA risk assessment auditing standards. " - George I. Victor, CPA, Partner in Charge of Quality Control, Holtz Rubenstein Reminick LLP "Author Lyn Graham gives practical, easy-to-understand guidance for documenting internal controls. I recommend this book for both my clients and our staff. It is very useful for auditors and clients alike." - David E. Adams, CPA, Partner, Geffen Mesher & Company "This book is an essential guide...and provides very practical advice about what to do(and what not to do) in making an investment in internal controls. The author's expensive experience as an audit firm partner and standard-setter are evident in the details provided. I also recommend this book to teaches of auditing and systems, as it provides a useful background to...how internal controls really should work in today's business environment." - Jean C. Bedard, CPA, PhD, Timothy B. Harbert Professor of Accountancy, Bentley College

Author: Tom Armstrong
Publisher: Wiley
ISBN: 9781558515031
Category : Computers
Languages : en
Pages : 629

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Book Description
Here is everything you need to know about creating and using ActiveX controls, from the perspective of a professional programmer. It tells what tools to use, what Microsoft standards to follow, and how to design specifically for the Web. The CD-ROM contains all the source code in the book, as well as more than 30 invaluable pre-built ActiveX controls to integrate into your programs.

Author: James Henry
Publisher: BlueVision, LLC
ISBN: 0972317902
Category :
Languages : en
Pages : 602

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Book Description
"Developing .NET Custom Controls and Designers Using C#" starts with an introduction to basic, but important, prerequisites, including data binding and event handling. It then goes into type conversion and editor implementation topics. The book discusses both Windows Forms and ASP.NET Web Forms, their basic architectures, and how to go about writing custom controls and designers to support these technologies.