Part 1 Basics of reliability: the medical device as an entity; the concept of failure; reliability versus assurance; device safety; device economics. Part 2 Medical device regulations and standards: the food and drug administration; the medical device directives; ISO 9000 series of standards; domestic standards; international standards. Part 3 Specifying and designing the product: defining the device; requirement engineering; risk management; liability; intellectual property; human factors; establishing and using metrics; good laboratory practices; hardware design; software design; software coding. Part 4 Testing and data analysis: the basis and type of testing; hardware verification and validation; software verification and validation; analysis of test results. Part 5 The manufacturing and maintenance process: configuration management; analysis of field data; appendix 1 - chi-square table; appendix 2 - percent rank tables; appendix 3 - addresses of standards and regulatory agencies; appendix 4 - detailed summary of the requirements of ISO 9000; appendix 5 - common failure modes; appendix 6 - glossary.