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.

section Section 1|1 pages

Standards and Regulations

chapter Chapter 1|17 pages

FDA Regulations

ByRichard C. Fries

chapter Chapter 2|27 pages

Preparing an FDA Submission

ByRichard C. Fries

chapter Chapter 3|26 pages

European Standards and Regulations

ByRichard C. Fries

chapter Chapter 4|32 pages

The Medical Device Directives

ByRichard C. Fries

chapter Chapter 5|26 pages

The Basics of ISO 9001

ByTina Juneau

chapter Chapter 6|15 pages

Design of Medical Devices for the Canadian Market

ByPaul Fabry

chapter Chapter 7|17 pages

Pacific Rim Standards and Regulations

ByRichard C. Fries

chapter Chapter 8|35 pages

Overview of Software Standards

ByNancy George

section Section 2|1 pages

Determining and Documenting Requirements

chapter Chapter 9|22 pages

Defining the Device

ByRichard C. Fries

chapter Chapter 10|21 pages

Documenting Product Requirements

ByRichard C. Fries

chapter Chapter 11|10 pages

Medical Device Records

ByRichard C. Fries

section Section 3|1 pages

The Design Phase

chapter Chapter 12|44 pages

Hazard and Risk Analysis

ByMarkus Weber

chapter Chapter 13|21 pages

Hardware Design

ByRichard C. Fries

chapter Chapter 14|26 pages

Software Design

BySherman Eagles

chapter Chapter 15|42 pages

Human Factors Engineering

ByRichard C. Fries

chapter Chapter 16|23 pages

Biocompatibility

ByRichard C. Fries

chapter Chapter 17|32 pages

Reliability Assurance

ByRichard C. Fries

chapter Chapter 18|43 pages

Product User Guides

ByMargaret Rickard

chapter Chapter 19|19 pages

Translation: “It’s A Small World After All”

ByMargaret Rickard

chapter Chapter 20|12 pages

Liability

ByRichard C. Fries

chapter Chapter 21|26 pages

Intellectual Property

ByRichard C. Fries

section Section 4|1 pages

Verification and Validation

chapter Chapter 22|24 pages

Testing

ByLisa Henn

chapter Chapter 23|22 pages

Overview of Verification and Validation for Embedded Software in Medical Systems

ByAndre Bloesch

chapter Chapter 24|27 pages

Software Verification and Validation

BySherman Eagles

chapter Chapter 25|28 pages

Reliability Evaluation

ByRichard C. Fries

chapter Chapter 26|17 pages

Analysis of Test Results

ByRichard C. Fries

section Section 5|1 pages

The Manufacturing/Field Phase

chapter Chapter 27|16 pages

Quality System Regulations and Manufacturing

ByRichard C. Fries

chapter Chapter 28|11 pages

Configuration Management

ByRichard C. Fries

chapter Chapter 29|9 pages

The Quality System Audit

ByTina Juneau

chapter Chapter 30|9 pages

Analysis of Field Data

ByRichard C. Fries