Medical Device Deployment

Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging…

Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the…

Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect…

Terminology used for medical components and accessories in safety reports and FDA CDRH documents during both pre and post approval periods of…

Issue associated with the incompatibility of any device and/or device components while being operated in the same use environment thereby leading to…

A physical object that is a medical device or a component or accessory of a medical device.