EBookClubs

Read Books & Download eBooks Full Online

EBookClubs

Read Books & Download eBooks Full Online

Book Medical Device Software Verification  Validation and Compliance

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."

Book Software Testing Basics

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.

Book Pharmaceutical Computer Systems Validation

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 773 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 regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Book DESIGN CONTROLS  RISK MANAGEMENT   PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

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.

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

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

Book Software Process Improvement and Capability Determination

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 294 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.

Book Medical Device Quality Assurance and Regulatory Compliance

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 497 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."

Book Software Process Improvement and Capability Determination

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 278 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.

Book Introduction to Medical Software

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.

Book Product Focused Software Process Improvement

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 340 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.

Book Validation Compliance Annual

    Book Details:
  • Author : International Validation Forum
  • Publisher : CRC Press
  • Release : 1995-02-17
  • ISBN : 9780824794590
  • Pages : 1114 pages

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."

Book Secure and Smart Cyber Physical Systems

Download or read book Secure and Smart Cyber Physical Systems written by Uttam Ghosh and published by CRC Press. This book was released on 2024-07-26 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cybersecurity is a paramount concern in both Internet of Things (IoT) and Cyber-Physical Systems (CPSs) due to the interconnected and often critical nature of these systems. The integration of AI/ML into the realm of IoT and CPS security has gained significant attention and momentum in recent years. The success of AI/ML in various domains has sparked interest in leveraging these technologies to enhance the security, resilience, and adaptability of IoT and CPS. Secure and Smart Cyber-Physical Systems provides an extensive exploration of AI/ML-based security applications in the context of IoT and CPS. Features Presents cutting-edge topics and research in IoT and CPS Includes contributions from leading worldwide researchers Focuses on CPS architectures for secure and smart environments Explores AI/ML and blockchain approaches for providing security and privacy to CPS including smart grids, smart cities, and smart healthcare Provides comprehensive guidance into the intricate world of software development for medical devices Covers a blueprint for the emergence of 6G communications technology in Industry 5.0 and federated-learning-based secure financial services This book covers state-of-the-art problems, existing solutions, and potential research directions for CPS researchers, scholars, and professionals in both industry and academia.

Book 21 CFR Part 11

    Book Details:
  • Author : Orlando López
  • Publisher : CRC Press
  • Release : 2004-01-15
  • ISBN : 1135488754
  • Pages : 287 pages

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

Book Structured Object Oriented Formal Language and Method

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 156 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.

Book The Practice of Formal Methods

Download or read book The Practice of Formal Methods written by Ana Cavalcanti and published by Springer Nature. This book was released on with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Fundamentals of IoT and Wearable Technology Design

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.