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 a much broader, higher-level picture than other books in this field, this book helps professionals think critically about software validation to build confidence in their software's safety and effectiveness. The book presents validation activities for each phase of the product 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.
|Publisher:||Artech House, Incorporated|
|Product dimensions:||7.40(w) x 10.30(h) x 1.10(d)|
About the Author
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.
Table of Contents
Background - Introduction. Regulatory Background. What is Validation, Why You Should Validate, and Why the FDA Says You Should Validate. The Role of the Organization in Validation. The Software Lifecycle. Verification & Validation. Validating Medical Device Software - The Lifecycle Approach to Validation. Supporting Processes that Span the Lifecycle. Concept Phase. Requirements Phase. Design Phase. Implementation Phase. Testing Phase. Maintenance Phase. Validating Quality and Production System Software - Why This Kind of Software Validation is Different. Regulatory Background. The Lifecycle Approach. The role of Vendor Selection in Validation of Q&PSS. Identifying Intended Use. Requirements for Fulfilling Intended Use. Risk Management. Configuration Management. Testing. Maintenance Phase. Summing It Up - Resources. Examples. Final Words of Advice.