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 […]
Category: Requirements
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 […]
ISO 14971
ISO 14971 is an international standard that specifies the requirements for risk management of medical devices. The standard was developed by the International Organization for Standardization (ISO) and […]