OSLC – Open Services for Lifecycle Collaboration
OSLC stands for Open Services for Lifecycle Collaboration. It is an open standard for integrating different software tools used in the software…
Category: Requirements
AAMI TIR45
AAMI TIR45 is a technical information report published by the Association for the Advancement of Medical Instrumentation (AAMI). The report provides…
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…
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…
IEC 62304: Medical Device Software Safety
IEC 62304 is an international standard that provides guidance on the software life cycle processes used in the development of medical device software. The…