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."

Software Testing Basics

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Author :
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781543269543
Total Pages : 0 pages
Book Rating : 4.2/5 (695 download)

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Book Synopsis Software Testing Basics by : Paul Felten

Download or read book Software Testing Basics written by Paul Felten and published by Createspace Independent Publishing Platform. This book was released on 2017-03-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Software Testing Basics contains the necessary software verification fundamentals for dedicated testers in the medical device industry. The methods and concepts within have been time-tested and conform to IEC 62304 and 21CFR820.30. Common myths are exposed and best practices revealed to improve knowledge, test efficiency, and compliance. After reading this book, new testers will have a solid foundation on which to start their careers on, and experienced testers will be able to identify inconsistencies and myths within their current test practices. Everything from creating requirements, to creating test cases is covered including test types, methods, and levels. Frequently asked questions such as "How do I know what to test?" is answered clearly and concisely.

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

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Author :
Publisher : CRC Press
ISBN 13 : 1040002358
Total Pages : 223 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by : Philip S. Cosgriff

Download or read book Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

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Author :
Publisher : Taylor & Francis
ISBN 13 : 1351704346
Total Pages : 326 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation by : Orlando Lopez

Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

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Author :
Publisher : Wasatch Consulting Resources LLC
ISBN 13 : 0692835415
Total Pages : 441 pages
Book Rating : 4.6/5 (928 download)

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Book Synopsis DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS by : Vernon Geckler

Download or read book DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Design Controls for the Medical Device Industry, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1351261460
Total Pages : 185 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Design Controls for the Medical Device Industry, Third Edition by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry, Third Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2019-08-02 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the 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. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements

Software Process Improvement and Capability Determination

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Author :
Publisher : Springer
ISBN 13 : 3319130366
Total Pages : 283 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Antanas Mitasiunas

Download or read book Software Process Improvement and Capability Determination written by Antanas Mitasiunas and published by Springer. This book was released on 2014-10-13 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 14th International Conference on Software Process Improvement and Capability Determination, SPICE 2014, held in Vilnius, Lithuania, in November 2014. The 21 revised full papers presented together with 6 short papers were carefully reviewed and selected from 49 submissions. The papers are organized in topical sections on developing process models for assessment; software process and models; software models and product lines; assessment; agile processes; processes improvement and VSE.

Pharmaceutical Computer Systems Validation

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Author :
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 798 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews r

Software Process Improvement and Capability Determination

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Author :
Publisher : Springer
ISBN 13 : 3642388337
Total Pages : 267 pages
Book Rating : 4.6/5 (423 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Tanja Woronowicz

Download or read book Software Process Improvement and Capability Determination written by Tanja Woronowicz and published by Springer. This book was released on 2013-05-21 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 13th International Conference on Software Process Improvement and Capability Determination, SPICE 2013, held in Bremen, Germany, in June 2013. The 21 revised full papers presented and 7 short papers were carefully reviewed and selected from numerous submissions. The papers are organized in topical sections on process quality; medical device software processes; design and use of process models; studies of software development; agile development; IT service management; assessment for diagnosis.

Introduction to Medical Software

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Author :
Publisher : Cambridge University Press
ISBN 13 : 1316514994
Total Pages : 341 pages
Book Rating : 4.3/5 (165 download)

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Book Synopsis Introduction to Medical Software by : Xenophon Papademetris

Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise and accessible overview of the design, implementation and management of medical software.

Product-Focused Software Process Improvement

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Author :
Publisher : Springer
ISBN 13 : 3319138359
Total Pages : 328 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Product-Focused Software Process Improvement by : Andreas Jedlitschka

Download or read book Product-Focused Software Process Improvement written by Andreas Jedlitschka and published by Springer. This book was released on 2014-11-13 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 15th International Conference on Product-Focused Software Process Improvement, PROFES 2014, held in Helsinki, Finland, in December 2014. The 18 revised full papers presented together with 14 short papers were carefully reviewed and selected from 45 initial submissions. The papers are organized in topical sections on agile development, decision-making, development practices and issues, product planning, and project management.

Structured Object-Oriented Formal Language and Method

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Author :
Publisher : Springer
ISBN 13 : 3642392776
Total Pages : 149 pages
Book Rating : 4.6/5 (423 download)

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Book Synopsis Structured Object-Oriented Formal Language and Method by : Shaoying Liu

Download or read book Structured Object-Oriented Formal Language and Method written by Shaoying Liu and published by Springer. This book was released on 2013-08-04 with total page 149 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed post-conference proceedings of the Second International Workshop on Structured Object-Oriented Formal Language, SOFL 2012, held in Kyoto, Japan, in November 2012. The 10 full papers presented were carefully reviewed and selected for inclusion in this book and address the following topics of interest: testing and tools; tools for specification; model checking; and application and prototyping.

Medical Device Quality Assurance and Regulatory Compliance

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Author :
Publisher : CRC Press
ISBN 13 : 9780824701772
Total Pages : 504 pages
Book Rating : 4.7/5 (17 download)

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Book Synopsis Medical Device Quality Assurance and Regulatory Compliance by : Richard C. Fries

Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."

Fundamentals of IoT and Wearable Technology Design

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Publisher : John Wiley & Sons
ISBN 13 : 1119617553
Total Pages : 304 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Fundamentals of IoT and Wearable Technology Design by : Haider Raad

Download or read book Fundamentals of IoT and Wearable Technology Design written by Haider Raad and published by John Wiley & Sons. This book was released on 2020-12-12 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this indispensable guide covering the fundamentals of IOT and wearable devices from a leading voice in the field Fundamentals of IoT and Wearable Technology Design delivers a comprehensive exploration of the foundations of the Internet of Things (IoT) and wearable technology. Throughout the textbook, the focus is on IoT and wearable technology and their applications, including mobile health, environment, home automation, and smart living. Readers will learn about the most recent developments in the design and prototyping of these devices. This interdisciplinary work combines technical concepts from electrical, mechanical, biomedical, computer, and industrial engineering, all of which are used in the design and manufacture of IoT and wearable devices. Fundamentals of IoT and Wearable Technology Design thoroughly investigates the foundational characteristics, architectural aspects, and practical considerations, while offering readers detailed and systematic design and prototyping processes of typical use cases representing IoT and wearable technology. Later chapters discuss crucial issues, including PCB design, cloud and edge topologies, privacy and health concerns, and regulatory policies. Readers will also benefit from the inclusion of: A thorough introduction to the applications of IoT and wearable technology, including biomedicine and healthcare, fitness and wellbeing, sports, home automation, and more Discussions of wearable components and technologies, including microcontrollers and microprocessors, sensors, actuators and communication modules An exploration of the characteristics and basics of the communication protocols and technologies used in IoT and wearable devices An overview of the most important security challenges, threats, attacks and vulnerabilities faced by IoT and wearable devices along with potential solutions Perfect for research and development scientists working in the wearable technology and Internet of Things spaces, Fundamentals of IoT and Wearable Technology Design will also earn a place in the libraries of undergraduate and graduate students studying wearable technology and IoT, as well as professors and practicing technologists in the area.

21 CFR Part 11

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Author :
Publisher : CRC Press
ISBN 13 : 1135488754
Total Pages : 287 pages
Book Rating : 4.1/5 (354 download)

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Book Synopsis 21 CFR Part 11 by : Orlando López

Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places

Validation Compliance Annual

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Author :
Publisher : CRC Press
ISBN 13 : 9780824794590
Total Pages : 1114 pages
Book Rating : 4.7/5 (945 download)

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Book Synopsis Validation Compliance Annual by : International Validation Forum

Download or read book Validation Compliance Annual written by International Validation Forum and published by CRC Press. This book was released on 1995-02-17 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Handbook of Terminology

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Author :
Publisher : John Benjamins Publishing Company
ISBN 13 : 902726306X
Total Pages : 275 pages
Book Rating : 4.0/5 (272 download)

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Book Synopsis Handbook of Terminology by : Abied Alsulaiman

Download or read book Handbook of Terminology written by Abied Alsulaiman and published by John Benjamins Publishing Company. This book was released on 2019-01-29 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: The current volume represents a revival of Arabic translation and terminology studies. These disciplines have been dominated by Western scholarship in recent decades, but in truth their historical tradition as a whole owes a great debt to Arabic scholarship. The first systematic translation activity ever organized was under the Abbasids in Baghdad in the 9th Century CE, and Arabic domination continued for several centuries before the tide turned. In this collection, the importance of the ongoing translation and terminology movement in the Arab world is revealed through the works of some of the most distinguished scholars, who investigate a wide range of relevant topics from the making of the first ever Arabic monolingual dictionary to modern-day localization into Arabic. Arabic terminology standardization as well as legal, medical, Sufi and Quranic terms — issues with both cultural and economic ramifications for the Arab world — are thoroughly examined, completing the solid framework of this rich tradition that still has a lot to offer.