Medical Device Software Verification, Validation and Compliance

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Author :
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)

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Book Synopsis Medical Device Software Verification, Validation and Compliance by : David A. Vogel

Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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."

Accelerated Testing and Validation

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Author :
Publisher : Elsevier
ISBN 13 : 0080488072
Total Pages : 257 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Accelerated Testing and Validation by : Alex Porter

Download or read book Accelerated Testing and Validation written by Alex Porter and published by Elsevier. This book was released on 2004-07-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Testing and Validation Methods is a cross-disciplinary guide that describes testing and validation tools and techniques throughout the product development process. Alex Porter not only focuses on what information is needed but also on what tools can produce the information in a timely manner. From the information provided, engineers and managers can determine what data is needed from a test and validation program and then how to select the best, most effective methods for obtaining the data.This book integrates testing and validation methods with a business perspective so readers can understand when, where, and how such methods can be economically justified. Testing and validation is about generating key information at the correct time so that sound business and engineering decisions can be made. Rather than simply describing various testing and validation techniques, the author offers readers guidance on how to select the best tools for a particular need, explains the appropriateness of different techniques to various situations and shows how to deploy them to ensure the desired information is accurately gathered. - Emphasizes developing a strategy for testing and validation - Teaches how to design a testing and validation program that deliver information in a timely and cost-effective manner

Method Validation in Pharmaceutical Analysis

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

AIAA Guide for the Verification and Validation of Computational Fluid Dynamics Simulations

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Author :
Publisher : AIAA (American Institute of Aeronautics & Astronautics)
ISBN 13 : 9781563472855
Total Pages : 0 pages
Book Rating : 4.4/5 (728 download)

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Book Synopsis AIAA Guide for the Verification and Validation of Computational Fluid Dynamics Simulations by : American Institute of Aeronautics and Astronautics

Download or read book AIAA Guide for the Verification and Validation of Computational Fluid Dynamics Simulations written by American Institute of Aeronautics and Astronautics and published by AIAA (American Institute of Aeronautics & Astronautics). This book was released on 1998 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document defines a number of key terms, discusses fundamental concepts, and specifies general procedures for conducting verification and validation of computational fluid dynamics simulations. It's goal is to provide a foundation for the major issues and concepts in verification and validation. However, it does not recommend standards in these areas because a number of important issues are not yet resolved.

Basic Method Validation

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Author :
Publisher : AACC Press
ISBN 13 : 9781886958197
Total Pages : 292 pages
Book Rating : 4.9/5 (581 download)

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Book Synopsis Basic Method Validation by : James O. Westgard

Download or read book Basic Method Validation written by James O. Westgard and published by AACC Press. This book was released on 2003-01-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.

Basic Method Validation and Verification, 4th Edition

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Author :
Publisher :
ISBN 13 : 9781886958333
Total Pages : 308 pages
Book Rating : 4.9/5 (583 download)

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Book Synopsis Basic Method Validation and Verification, 4th Edition by : James O. Westgard

Download or read book Basic Method Validation and Verification, 4th Edition written by James O. Westgard and published by . This book was released on 2020-08 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Statistical Procedures for the Medical Device Industry

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Author :
Publisher :
ISBN 13 : 9780963512291
Total Pages : 0 pages
Book Rating : 4.5/5 (122 download)

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Book Synopsis Statistical Procedures for the Medical Device Industry by : Wayne A. Taylor

Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Verification Handbook

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Publisher :
ISBN 13 : 9781312023130
Total Pages : 120 pages
Book Rating : 4.0/5 (231 download)

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Book Synopsis Verification Handbook by : Craig Silverman

Download or read book Verification Handbook written by Craig Silverman and published by . This book was released on 2014 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Verification of Reactive Systems

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3662107783
Total Pages : 608 pages
Book Rating : 4.6/5 (621 download)

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Book Synopsis Verification of Reactive Systems by : Klaus Schneider

Download or read book Verification of Reactive Systems written by Klaus Schneider and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a solid foundation of the most important formalisms used for specification and verification of reactive systems. In particular, the text presents all important results on m-calculus, w-automata, and temporal logics, shows the relationships between these formalisms and describes state-of-the-art verification procedures for them. It also discusses advantages and disadvantages of these formalisms, and shows up their strengths and weaknesses. Most results are given with detailed proofs, so that the presentation is almost self-contained. Includes all definitions without relying on other material Proves all theorems in detail Presents detailed algorithms in pseudo-code for verification as well as translations to other formalisms

Managing the Testing Process

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0471449342
Total Pages : 530 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Managing the Testing Process by : Rex Black

Download or read book Managing the Testing Process written by Rex Black and published by John Wiley & Sons. This book was released on 2003-08-16 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: An updated edition of the best tips and tools to plan, build, and execute a structured test operation In this update of his bestselling book, Rex Black walks you through how to develop essential tools and apply them to your test project. He helps you master the basic tools, apply the techniques to manage your resources, and give each area just the right amount of attention so that you can successfully survive managing a test project! Offering a thorough review of the tools and resources you will need to manage both large and small projects for hardware and software, this book prepares you to adapt the concepts across a broad range of settings. Simple and effective, the tools comply with industry standards and bring you up to date with the best test management practices and tools of leading hardware and software vendors. Rex Black draws from his own numerous testing experiences-- including the bad ones, so you can learn from his mistakes-- to provide you with insightful tips in test project management. He explores such topics as: Dates, budgets, and quality-expectations versus reality Fitting the testing process into the overall development or maintenance process How to choose and when to use test engineers and technicians, contractors and consultants, and external test labs and vendors Setting up and using an effective and simple bug-tracking database Following the status of each test case The companion Web site contains fifty tools, templates, and case studies that will help you put these ideas into action--fast!

Joe Celko's Complete Guide to NoSQL

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Author :
Publisher : Newnes
ISBN 13 : 0124072208
Total Pages : 245 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Joe Celko's Complete Guide to NoSQL by : Joe Celko

Download or read book Joe Celko's Complete Guide to NoSQL written by Joe Celko and published by Newnes. This book was released on 2013-10-07 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Joe Celko's Complete Guide to NoSQL provides a complete overview of non-relational technologies so that you can become more nimble to meet the needs of your organization. As data continues to explode and grow more complex, SQL is becoming less useful for querying data and extracting meaning. In this new world of bigger and faster data, you will need to leverage non-relational technologies to get the most out of the information you have. Learn where, when, and why the benefits of NoSQL outweigh those of SQL with Joe Celko's Complete Guide to NoSQL. This book covers three areas that make today's new data different from the data of the past: velocity, volume and variety. When information is changing faster than you can collect and query it, it simply cannot be treated the same as static data. Celko will help you understand velocity, to equip you with the tools to drink from a fire hose. Old storage and access models do not work for big data. Celko will help you understand volume, as well as different ways to store and access data such as petabytes and exabytes. Not all data can fit into a relational model, including genetic data, semantic data, and data generated by social networks. Celko will help you understand variety, as well as the alternative storage, query, and management frameworks needed by certain kinds of data. - Gain a complete understanding of the situations in which SQL has more drawbacks than benefits so that you can better determine when to utilize NoSQL technologies for maximum benefit - Recognize the pros and cons of columnar, streaming, and graph databases - Make the transition to NoSQL with the expert guidance of best-selling SQL expert Joe Celko

PDCA/Test

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Author :
Publisher : CRC Press
ISBN 13 : 1000170136
Total Pages : 422 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis PDCA/Test by : William Lewis

Download or read book PDCA/Test written by William Lewis and published by CRC Press. This book was released on 2020-03-05 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most manuals assume software testing is being performed as part of a well-defined, structured development cycle based on clearly stated requirements and standards. Unfortunately, this is not often the case in the real world. Indeed, the one true constant in software development is change. PDCA/TEST presents a continuous quality framework bas

The Complete Guide to the ABC Molecular Biology Certification Exam

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Author :
Publisher : CRC Press
ISBN 13 : 1000033597
Total Pages : 221 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis The Complete Guide to the ABC Molecular Biology Certification Exam by : Tiffany Roy

Download or read book The Complete Guide to the ABC Molecular Biology Certification Exam written by Tiffany Roy and published by CRC Press. This book was released on 2020-04-03 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2009, the National Academy of Sciences (NAS) authored the report Strengthening Forensic Science in the United States: A Path Forward. In it, the Committee expressed the need for accreditation and certification. Accreditation, long recognized by public labs as an important benchmark in quality, was recognized as an important way to standardize laboratories that provide forensic services. Certification can play an important role as a method of oversight in the forensic sciences—something also recommended by the - National Commission on Forensic Science in October 2014. The Complete Guide to the ABC's Molecular Biology is a professional certification examination preparation text for forensic scientists taking the American Board of Criminalistics Examination in Molecular Biology. The book serves as a resource for forensic scientists—who are facing more and more pressure to become certified—to support them in their pursuit of forensic certification. In the years since the NAS report was published, there has been increased discussion of forensic certification requirements. ABC’s Molecular Biology exam is a quality certification, and learning the concepts for it will invariably help any professional working in the field. The book prepares readers in all relevant topic areas, including: accreditation, safety, biological screen principles, anatomy and cell biology, crime scene and evidence handling, concepts in genetics, biochemistry, statistics, DNA evidence, and DNA testing. The book will be particularly helpful for forensic science laboratory technicians, police and investigations professionals, forensic serology and DNA analysts, attorneys, and forensic science students. This study guide follows the guidelines for the exam and presents all the information necessary to prepare individuals to pass the exam.

Verification, Validation, and Testing of Engineered Systems

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Publisher : John Wiley & Sons
ISBN 13 : 1118029313
Total Pages : 723 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Verification, Validation, and Testing of Engineered Systems by : Avner Engel

Download or read book Verification, Validation, and Testing of Engineered Systems written by Avner Engel and published by John Wiley & Sons. This book was released on 2010-11-19 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: Systems' Verification Validation and Testing (VVT) are carried out throughout systems' lifetimes. Notably, quality-cost expended on performing VVT activities and correcting system defects consumes about half of the overall engineering cost. Verification, Validation and Testing of Engineered Systems provides a comprehensive compendium of VVT activities and corresponding VVT methods for implementation throughout the entire lifecycle of an engineered system. In addition, the book strives to alleviate the fundamental testing conundrum, namely: What should be tested? How should one test? When should one test? And, when should one stop testing? In other words, how should one select a VVT strategy and how it be optimized? The book is organized in three parts: The first part provides introductory material about systems and VVT concepts. This part presents a comprehensive explanation of the role of VVT in the process of engineered systems (Chapter-1). The second part describes 40 systems' development VVT activities (Chapter-2) and 27 systems' post-development activities (Chapter-3). Corresponding to these activities, this part also describes 17 non-testing systems' VVT methods (Chapter-4) and 33 testing systems' methods (Chapter-5). The third part of the book describes ways to model systems' quality cost, time and risk (Chapter-6), as well as ways to acquire quality data and optimize the VVT strategy in the face of funding, time and other resource limitations as well as different business objectives (Chapter-7). Finally, this part describes the methodology used to validate the quality model along with a case study describing a system's quality improvements (Chapter-8). Fundamentally, this book is written with two categories of audience in mind. The first category is composed of VVT practitioners, including Systems, Test, Production and Maintenance engineers as well as first and second line managers. The second category is composed of students and faculties of Systems, Electrical, Aerospace, Mechanical and Industrial Engineering schools. This book may be fully covered in two to three graduate level semesters; although parts of the book may be covered in one semester. University instructors will most likely use the book to provide engineering students with knowledge about VVT, as well as to give students an introduction to formal modeling and optimization of VVT strategy.

IB Chinese B (HL) 5000 Classified Vocabulary PDF Book -The complete Reference for Your Success

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Author :
Publisher : Legoo Mandarin
ISBN 13 :
Total Pages : 193 pages
Book Rating : 4./5 ( download)

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Book Synopsis IB Chinese B (HL) 5000 Classified Vocabulary PDF Book -The complete Reference for Your Success by : DAVID

Download or read book IB Chinese B (HL) 5000 Classified Vocabulary PDF Book -The complete Reference for Your Success written by DAVID and published by Legoo Mandarin. This book was released on 2020-06-14 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is for IB Chinese B (HL) 5000 Classified Vocabulary Our first book in this series is “IB Mandarin Chinese B (Ab Initio) Classified Vocabulary” is based on “IB Chinese B ab initao Syllabus’. There is no official Vocabulary for IB Chinese B ( SL) , IB Chinese B ( HL), IB Chinese A ( SL, HL). We publish this series by referring HSK new and HSK (old, before 2009). • IB Chinese B ( SL) 2500 Classified Vocabulary is referring HSK 5 Vocabulary with the Best English Translation for better understanding and our many years' experience in IB, HSK and GCSE teaching. • IB Chinese B ( HL) 5000 Classified Vocabulary is referring HSK 6 Vocabulary with the Best English Translation for better understanding and our many years' experience in IB, HSK and GCSE teaching. • IB Chinese A (SL & HL) 9000 Classified Vocabulary is referring HSK 6 Vocabulary plus all required vocabulary in China (similar to K1-K12). We give HSK level classification which will give you a cross reference for your Chinese standard. Many students call it "LIFE SAVING" for their exam. The book give a quick revision for your coming exam! Grab it! Thanks for your support for us creating better contents for you!

Guideline on General Principles of Process Validation

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Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline on General Principles of Process Validation by :

Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

HSMV 2020

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Publisher : IOS Press
ISBN 13 : 1643681257
Total Pages : 294 pages
Book Rating : 4.6/5 (436 download)

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Book Synopsis HSMV 2020 by : E. Begovic

Download or read book HSMV 2020 written by E. Begovic and published by IOS Press. This book was released on 2020-11-03 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the proceedings of the 12th International Symposium on High Speed Marine Vehicles, held virtually as an e-conference for the first time on 15 and 16 October 2020. High Speed Marine Vehicles Conference has almost 30-year history since the first Conference held in Naples in 1991. Since then, it has been an opportunity to present and discuss developments in the design, construction and operation of High Speed Marine Vessels. More than 40 abstracts were submitted for this edition of the conference, and following a rigorous review process, 26 papers were selected for inclusion in this book. These have been divided into 7 sections: CFD/EFD/sea trials; hydrofoils; multi-hull hydrodynamics; planing-hull hydrodynamics; propulsion and ship machinery; second generation intact stability criteria; and structures, loads, strength and materials. Topics covered include updated aspects of and developments in ship design, numerical and experimental hydrodynamics, seakeeping and maneuvering, and marine structures and machinery. This publication will be of interest to researchers from academia, industry, government agencies and certifying authorities, as well as designers and operators of high-speed vessels.