Medical Device Software Verification, Validation and Compliance PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Medical Device Software Verification, Validation and Compliance PDF full book. Access full book title Medical Device Software Verification, Validation and Compliance by David A. Vogel. Download full books in PDF and EPUB format.
Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
Get Book Here
Book Description
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."
Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
Get Book Here
Book Description
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."
Author: Philip S. Cosgriff
Publisher: CRC Press
ISBN: 1040002358
Category : Science
Languages : en
Pages : 223
Get Book Here
Book Description
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
Author: Antanas Mitasiunas
Publisher: Springer
ISBN: 3319130366
Category : Business & Economics
Languages : en
Pages : 294
Get Book Here
Book Description
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.
Author: Tanja Woronowicz
Publisher: Springer
ISBN: 3642388337
Category : Business & Economics
Languages : en
Pages : 278
Get Book Here
Book Description
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.
Author: Xenophon Papademetris
Publisher: Cambridge University Press
ISBN: 1316514994
Category : Business & Economics
Languages : en
Pages : 341
Get Book Here
Book Description
A concise and accessible overview of the design, implementation and management of medical software.
Author: Andreas Jedlitschka
Publisher: Springer
ISBN: 3319138359
Category : Computers
Languages : en
Pages : 340
Get Book Here
Book Description
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.
Author: Dean Leffingwell
Publisher: Pearson Education
ISBN: 0321630068
Category : Computers
Languages : en
Pages : 635
Get Book Here
Book Description
“Companies have been implementing large agile projects for a number of years, but the ‘stigma’ of ‘agile only works for small projects’ continues to be a frequent barrier for newcomers and a rallying cry for agile critics. What has been missing from the agile literature is a solid, practical book on the specifics of developing large projects in an agile way. Dean Leffingwell’s book Scaling Software Agility fills this gap admirably. It offers a practical guide to large project issues such as architecture, requirements development, multi-level release planning, and team organization. Leffingwell’s book is a necessary guide for large projects and large organizations making the transition to agile development.” —Jim Highsmith, director, Agile Practice, Cutter Consortium, author of Agile Project Management “There’s tension between building software fast and delivering software that lasts, between being ultra-responsive to changes in the market and maintaining a degree of stability. In his latest work, Scaling Software Agility, Dean Leffingwell shows how to achieve a pragmatic balance among these forces. Leffingwell’s observations of the problem, his advice on the solution, and his description of the resulting best practices come from experience: he’s been there, done that, and has seen what’s worked.” —Grady Booch, IBM Fellow Agile development practices, while still controversial in some circles, offer undeniable benefits: faster time to market, better responsiveness to changing customer requirements, and higher quality. However, agile practices have been defined and recommended primarily to small teams. In Scaling Software Agility, Dean Leffingwell describes how agile methods can be applied to enterprise-class development. Part I provides an overview of the most common and effective agile methods. Part II describes seven best practices of agility that natively scale to the enterprise level. Part III describes an additional set of seven organizational capabilities that companies can master to achieve the full benefits of software agility on an enterprise scale. This book is invaluable to software developers, testers and QA personnel, managers and team leads, as well as to executives of software organizations whose objective is to increase the quality and productivity of the software development process but who are faced with all the challenges of developing software on an enterprise scale.
Author: Shaoying Liu
Publisher: Springer
ISBN: 3642392776
Category : Computers
Languages : en
Pages : 156
Get Book Here
Book Description
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.
Author: Jens Weber
Publisher: Springer
ISBN: 3642390889
Category : Computers
Languages : en
Pages : 232
Get Book Here
Book Description
This book constitutes the thoroughly refereed post-conference proceedings of the Second International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2012, held in Paris, France, in August 2012. The 11 revised full papers presented together with 3 short papers in this volume were carefully reviewed and selected from 26 submissions. Topics of interest covered in this volume are such as software engineering; systems engineering; data engineering; applied mathematics; and psychology.
Author: Ana Cavalcanti
Publisher: Springer Nature
ISBN: 3031666763
Category :
Languages : en
Pages : 337
Get Book Here
Book Description
