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…
Tag: Compliance
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…
ISO 14971
ISO 14971 is an international standard that specifies the requirements for risk management of medical devices. The standard was developed by the…
ISO 13485
ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. The standard outlines…