ABSTRACT
First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
TABLE OF CONTENTS
section Section 1|1 pages
Standards and Regulations
section Section 2|1 pages
Determining and Documenting Requirements
section Section 3|1 pages
The Design Phase
section Section 4|1 pages
Verification and Validation
chapter Chapter 23|22 pages
Overview of Verification and Validation for Embedded Software in Medical Systems
section Section 5|1 pages
The Manufacturing/Field Phase
