Drug–device combinations, device constituent parts, and software/device considerations
5 terms
A product composed of two or more regulated components (drug, device, biologic) that are physically, chemically, or otherwise combined or co-packaged and intended for use together.
Protection of connected devices/software against security threats that can affect safety, effectiveness, and data integrity, including lifecycle vulnerability management.
A discipline evaluating how users interact with a product (often devices) to reduce use errors and improve safety through design and testing.
Software intended to be used for one or more medical purposes without being part of a hardware medical device, with specific regulatory expectations.