Medical Device Software Verification, Validation, and Compliance

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).

David A. Vogel is founder and president of Intertech Engineering Associates, Inc. in Westwood, Massachusetts. The company specializes in the management of hardware and embedded software development and verification/validation projects for medical devices. He has also served as principal bioengineer at Becton Dickinson Medical Systems, and as software engineer for Honeywell Information Systems. He has earned degrees in biomedical engineering and computer science from the University of Michigan and Massachusetts Institute of Technology.