Medical Device Software Verification, Validation and Compliance

Author: David A. Vogel

Publisher: Artech House

ISBN: 1596934239

Category: Biomedical engineering

Page: 444

View: 8970

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."
Posted in Biomedical engineering

Software Process Improvement and Capability Determination

13th International Conference, SPICE 2013, Bremen, Germany, June 4-6, 2013. Proceedings

Author: Tanja Woronowicz,Terry Rout,Rory V. O’Connor,Alec Dorling

Publisher: Springer

ISBN: 3642388337

Category: Business & Economics

Page: 267

View: 3351

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.
Posted in Business & Economics

Medizinische Informatik kompakt

Ein Kompendium für Mediziner, Informatiker, Qualitätsmanager und Epidemiologen

Author: Roswitha Jehle,Johanna Christina Czeschik,Torsten Freund,Ernst Wellnhofer

Publisher: Walter de Gruyter GmbH & Co KG

ISBN: 3110389576

Category: Medical

Page: 520

View: 4929

Das kompakte Lehrbuch gibt einen umfassenden Überblick über die informatischen Grundlagen zur Signal-, Bild- und Datenverarbeitung sowie zu vernetzten Systemen. Es richtet sich an Ärzte, Studenten der Informatik und Medizininformatik, DRG-Beauftragte, Medizintechniker, Gerätebeauftragte und Leiter von Telemedizinprojekten. Das Buch deckt das Prüfungsgebiet der Zusatzbezeichnung Medizinische Informatik ab.
Posted in Medical

Software Process Improvement and Capability Determination

14th International Conference, SPICE 2014, Vilnius, Lithuania, November 4-6, 2014. Proceedings

Author: Antanas Mitasiunas,Terry Rout,Rory V. O’Connor,Alec Dorling

Publisher: Springer

ISBN: 3319130366

Category: Business & Economics

Page: 283

View: 6600

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.
Posted in Business & Economics

Safe and Sound Software

Creating an Efficient and Effective Quality System for Software Medical Device Organizations

Author: Thomas H. Faris

Publisher: ASQ Quality Press

ISBN: 9780873896740

Category: Business & Economics

Page: 354

View: 2951

"This book provides information and recommendations to help regulatory affairs and quality managers, and consultants of software medical device design and development organizations, navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system. Software organization executives, functional managers, and other interested coworkers can also use this book to secure a general understanding of the subject matter."--BOOK JACKET.
Posted in Business & Economics

Pharmaceutical Computer Systems Validation

Quality Assurance, Risk Management and Regulatory Compliance

Author: Guy Wingate

Publisher: CRC Press

ISBN: 1420088955

Category: Medical

Page: 798

View: 791

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. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include: GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ICH Guidance Q8, Q9, and Q10 expectations FDA cGMPs for the 21st Century Initiative and associated guidance PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment the indirect developments from FDA/EU/Japan regulators and industry the role of QA department, and internal and external suppliers the integration of computer systems validation into single overall approach for wider system practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system managing outsource partners and handling legacy systems topical issues uncovered by regulatory authorities including US FDA
Posted in Medical

Software für Medizingeräte

Die praktische Auslegung und Umsetzung der gesetzlichen Standards - für Entwicklungsleiter

Author: Georg Heidenreich,Gerd Neumann

Publisher: John Wiley & Sons

ISBN: 3895789305

Category: Science

Page: 272

View: 7333

Programme für Medizingeräte müssen der Norm IEC 62304 entsprechen. Diese Software-Norm ist sehr vielseitig und eignet sich für alle möglichen Projektarten und -größen. Immer wieder treten dabei Spezialfälle auf, in denen die Norm individuell ausgelegt werden muss. Aus der Mitarbeit an der Norm, einer umfangreichen FAQ-Liste, der Beratung von Software-Entwicklern und vielen Diskussionen und Schulungen haben die Autoren eine Fülle von Erfahrungen gesammelt, die sie in dem Buch präsentieren. Dabei nutzen sie den Arbeitsablauf des Praktikers, um auf die möglichen Fallbeispiele und deren Lösung hinzuführen. Entwicklungsleiter, Programmierer, Qualitätsverantwortliche sowie Studenten der Medizintechnik erhalten mit diesem kompakten Buch eine praktische und vielseitige Auslegung der gesetzlichen Anforderungen an Software-Entwicklungsprozesse. Entwicklungsleiter finden darin eine normgerechte Vorgehensweise für ihre Prozesse, Qualitätsverantwortliche Informationen zu Koordination, Dokumentation und Controlling und Programmierer eine Einführung in die Umsetzung der anwendbaren Norm aus ihrer Sicht. Die Autoren machen dabei deutlich, was der Entwickler beachten muss und wo für ihn die Verantwortung und damit verbunden auch die Haftung für sein Produkt liegen.
Posted in Science

Vom Mythos des Mann-Monats

Author: Frederick P. Brooks

Publisher: mitp Verlags GmbH & Co. KG

ISBN: 9783826613555

Category:

Page: 343

View: 3194

Posted in

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Author: Carmen Medina

Publisher: CRC Press

ISBN: 0824758749

Category: Medical

Page: 704

View: 7782

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Posted in Medical

Medical Device Quality Assurance and Regulatory Compliance

Author: Richard C. Fries

Publisher: CRC Press

ISBN: 9780824701772

Category: Medical

Page: 496

View: 9868

"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."
Posted in Medical

Software Testing Basics

Software Verification Fundamentals for Dedicated Testers in the Medical Device Industry

Author: Paul Felten

Publisher: Createspace Independent Publishing Platform

ISBN: 9781543269543

Category:

Page: 144

View: 7704

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.
Posted in

Sterilization of Medical Devices

Author: Anne Booth

Publisher: CRC Press

ISBN: 9781574910872

Category: Medical

Page: 424

View: 5825

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Posted in Medical

Consultants and Consulting Organizations Directory

Author: Paul Wasserman,Janice W. McLean

Publisher: Gale / Cengage Learning

ISBN: N.A

Category: Business consultants

Page: N.A

View: 3247

Indexes are arranged by geographic area, activities, personal name, and consulting firm name.
Posted in Business consultants

App4U

Mehrwerte durch Apps im B2B und B2C

Author: Christian Aichele,Marius Schönberger

Publisher: Springer-Verlag

ISBN: 3834824364

Category: Computers

Page: 405

View: 5013

Proprietäre und monolithische Softwaresysteme haben die Wirtschaft in den letzten Jahrzehnten geprägt. Ohne die digitale Unterstützung der Geschäftsprozesse ist kein Unternehmen wettbewerbsfähig. Die Revolution wird durch den Consumer Bereich vorangetrieben, die Geschäftsprozesse werden mobil und ubiquitär. Konsumenten im B2C und Unternehmen im B2B werden zukünftig permanent in Kontakt treten können, die one-to-one Kommunikation wird durch einen many-to-many Informationsaustausch ersetzt werden.​
Posted in Computers

Medical Device Register

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Medical instruments and apparatus

Page: N.A

View: 537

Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Posted in Medical instruments and apparatus

Pharmaceutical Computer Validation Introduction Guidebook

Author: Daniel Farb,Bruce Gordon

Publisher: UniversityOfHealthCare

ISBN: 1594912629

Category: Medical

Page: 111

View: 1708

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.
Posted in Medical

Der rational unified process

eine Einführung

Author: Philippe Kruchten

Publisher: Pearson Deutschland GmbH

ISBN: 9783827315434

Category:

Page: 269

View: 2138

Posted in