Model-Based Systems Engineering (MBSE)
Model-Based Systems Engineering (MBSE) is an approach to systems engineering that emphasizes the use of models throughout the development lifecycle. MBSE is based on the idea that models […]
Insights
AAMI TIR45
AAMI TIR45 is a technical information report published by the Association for the Advancement of Medical Instrumentation (AAMI). The report provides guidance on the use of the International […]
21 CFR 820.30
21 CFR 820.30 is a regulation that outlines the requirements for design controls for medical devices in the United States. The regulation applies to all medical device manufacturers […]
CFR Part 11
CFR Part 11 refers to the electronic records and electronic signatures regulations set forth by the US Food and Drug Administration (FDA) under Title 21 of the Code […]
IEC 62304
IEC 62304 is an international standard that provides guidance on the software life cycle processes used in the development of medical device software. The standard outlines the requirements […]