ABSTRACT
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and qua
TABLE OF CONTENTS
part |20 pages
Section 1 Standards and Regulations
part |2 pages
Section 2 Determining and Documenting Requirements
part |2 pages
Section 3 The Design Phase
part |2 pages
Section 4 Verification and Validation
part |2 pages
Section 5 The Manufacturing/Field Phase