Handbook of Medical Device Design

Section - 1: Standards and Regulations FDA Regulations Preparing and FDA Submission European Standards and Regulations The Medical Device Directives The Basics of ISO 9001 Design of Medical Devices for the Canadian Market Pacific Rim Standards and Regulations Overview of Software Standards Section - 2: Determining and Documenting Requirements Defining the Devices Documenting Product Requirements Medical Device Records Section - 3: The Design Phase Hazard and Risk Analysis Hardware Design Software Design Human Factors Engineering Biocompatibility Reliability Assurance Product User Guides Translation: "It's a Small World After All" Liability Intellectual Property Section - 4: Verification and Validation Overview of Verification and Validation for Embedded Software in Medical Systems Software Verification and Validation Reliability Evaluation Analysis of Test Results Section - 5: The Manufacturing/Field Phase Quality System Regulations and Manufacturing Configuration Management The Quality System Audit Analysis of Field Data Appendices Appendix - 1: Chi Square Table Appendix - 2: Percent Rank Tables Appendix - 3: Glossary