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

part |20 pages

Section 1 Standards and Regulations

chapter 2|28 pages

Preparing an FDA Submission

chapter 3|26 pages

European Standards and Regulations

chapter 4|32 pages

The Medical Device Directives

chapter 5|26 pages

The Basics of ISO 9001

chapter 7|18 pages

Pacific Rim Standards and Regulations

chapter 8|36 pages

Overview of Software Standards

part |2 pages

Section 2 Determining and Documenting Requirements

chapter 9|22 pages

Defining the Device

chapter 10|22 pages

Documenting Product Requirements

chapter 11|10 pages

Medical Device Records

part |2 pages

Section 3 The Design Phase

chapter 12|44 pages

Hazard and Risk Analysis

chapter 13|22 pages

Hardware Design

chapter 14|26 pages

Software Design

chapter 15|42 pages

Human Factors Engineering

chapter 16|24 pages

Biocompatibility

chapter 17|32 pages

Reliability Assurance

chapter 18|44 pages

Product User Guides

chapter 19|20 pages

Translation: "It's A Small World After All"

chapter 20|12 pages

Liability

chapter 21|26 pages

Intellectual Property

part |2 pages

Section 4 Verification and Validation

chapter 22|24 pages

Testing

chapter 24|28 pages

Software Verification and Validation

chapter 25|28 pages

Reliability Evaluation

chapter 26|18 pages

Analysis of Test Results

part |2 pages

Section 5 The Manufacturing/Field Phase

chapter 27|16 pages

Quality System Regulations and Manufacturing

chapter 28|12 pages

Configuration Management

chapter 29|10 pages

The Quality System Audit

chapter 30|10 pages

Analysis of Field Data