Combination Products & Devices

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.