MDS2 (Medical Device)
Device description and disclosure (2.3.1 and 2.3.2) – MDS2 (Medical Device)

MDS2 (Medical Device) DOC: Device description: identify the device, its networked use, vulnerability disclosure, ISAO membership, diagrams and SaMD status

What does DOC require?

The device description section identifies: the manufacturer's name (DOC-1); a device description in standard terms (FDA product code, ECRI device code or another generic name), never an internal marketing, trademark or copyrighted product name (DOC-2); the marketed model as on the nameplate, identification tag or catalogue (DOC-3); the manufacturer's document identifier (DOC-4); a role or department email and main phone number (DOC-5); the device's intended function and use when connected to the customer network (DOC-6); the release date (DOC-7). It then asks whether the manufacturer runs a coordinated vulnerability disclosure programme for the device, with details in a note (DOC-8); whether it is a member of any ISAO (Information Sharing and Analysis Organization) (DOC-9); whether a network or data-flow diagram of connections to other components or external resources exists (DOC-10); and whether the device is Software as a Medical Device (DOC-11), and if so whether it contains an operating system (11.1), relies on one the owner or operator provides (11.2), or is hosted by the manufacturer (11.3) or by the customer (11.4).

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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