Richard Fries, PE, CSQE, CRE, is president of ISORel, Inc., a consulting firm located in Fitchburg, Wisconsin. He is a licensed professional engineer in the state of Wisconsin and is certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. Mr. Fries is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee that developed IEC 62304. He was also a member of the AAMI Technical Committee that developed ISO 13485.

The Basics of Reliability: Reliability. The Concept of Failure. The Product Design and Development Process. The Concept Phase: Defining the Device.Safety and Risk Management.Documents and Deliverables. The Feasibility Phase: The FDA.The Medical Devices Directives. Important Medical Device Standards. Human Factors. Requirements Engineering. Liability. Intellectual Property. The Project Team. The Reliability Goal and Plan. Documents and Deliverables. The Design Phase:Hardware Design. Hardware Risk Analysis. Design and Project Metrics. Design for Six Sigma. Software Design. Software Coding. Software Risk Analysis. Software Metrics. Documents and Deliverables. Verification and Validation: The Basis and Types of Testing. Hardware Verification and Validation. Hardware Data Analysis. Software Verification and Validation. Software Data Analysis. Documents and Deliverables. Design Transfer and Manufacturing: Transfer to Manufacturing. Hardware Manufacturing. Software Manufacturing. Configuration Management. Documents and Deliverables. Field Activity: Analysis of Field Data. Monitored Activity. Appendices. Index.