Software Development Practice for FDA-Compliant Medical Devices

Software development in medical devices by implementing lightweight processes in formal regulatory environments is an issue. This paper describes software development practice with the project of Digital Subtraction Angiography (DSA) medical device, and introduces experiences to ensure FDA regulatory compliance In addition, we introduce a hybrid methodology adopted in our software development process which is to use agile method to reduce project risk, and use formal waterfall-like lifecycle to create documents.