Medical Device Software Verification Validation and Compliance 1 Har Dvdr 1st Edition by David Vogel ISBN 978-1596934221 1596934220

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Product details: 

ISBN 10:   1596934220

ISBN 13: 978-1596934221

Author: David A. Vogel

Note: This is a print on demand, reproduction of the original title and does not include any DVD

Here s 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 software s 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, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i).

Table of contents: 

Chapter 1 — The Evolution of Medical Device Software Validation and the Need for This Book
Chapter 2 — Regulatory Background
Chapter 3 — The FDA Software Validation Regulations and Why You Should Validate Software Anyway
Chapter 4 — Organizational Considerations for Software Validation
Chapter 5 — The Software Development Life Cycle
Chapter 6 — Verification and Validation: What They Are, What They Are Not
Chapter 7 — The Life Cycle Approach to Software Validation
Chapter 8 — Supporting Activities that Span the Life Cycle: Risk Management
Chapter 9 — Other Supporting Activities: Planning, Reviews, Configuration Management, and Defect Management
PART II — Validation of Medical Device Software
Chapter 10 — The Concept Phase Activities
Chapter 11 — The Software Requirements Phase Activities
Chapter 12 — The Design and Implementation Phase Activities
Chapter 13 — The Testing Phase Activities
Chapter 14 — The Maintenance Phase Validation Activities
PART III — Validation of Non-Device Software
Chapter 15 — Validating Automated Process Software: Background
Chapter 16 — Planning Validation for Non-Device Software
Chapter 17 — Intended Use and the Requirements for Fulfilling Intended Use
Chapter 18 — Risk Management and Configuration Management of Non-Device Software: Activities that Span the Life Cycle
Chapter 19 — Non-Device Testing Activities to Support Validation
Chapter 20 — Non-Device Software Maintenance and Retirement Activities

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Tags: David Vogel, Medical Device Software, Verification Validation, 1 Har Dvdr