Handbook of Medical Device Design

摘要: Standards and regulations: FDA regulations preparing an submission European standards the medical device directives basics of ISO 9001 design devices for Canadian market Pacific Rim overview software standards. Determining documenting requirements: defining product requirements records. The phase: hazard risk analysis hardware human factors engineering biocompatibility reliability assurance user guides translation - it's a small world after all liability intellectual property. Verification validation: testing verification validation embedded in evaluation test results. manufacturing/field quality system manufacturing configuration management audit field data. Appendices: Chi Square table percent rank tables.