MDS2 (Medical Device)
Updates, software supply chain and hardening (2.3.7, 2.3.12, 2.3.17 to 2.3.20) – MDS2 (Medical Device)

MDS2 (Medical Device) SBOM: SBOM Software bill of materials: disclose whether an SBOM exists, its format and fields, how to list installed components and how it is updated

The SBOM lists every software component incorporated in the device for the HDO's operational security planning and supports the RDMP section; MDS2 does not prescribe a description method but asks the manufacturer to state the one used (ISO/IEC 19770-2 and NISTIR 8060 are examples), and all or part of an SBOM with confidential content may be released under a non-disclosure agreement. Questions: is an SBOM available for the product, and how (table in the form, hyperlink to an online version, NDA) (SBOM-1); does it follow a standard or common method of describing components (SBOM-2), identifying the components (2.1), their developer or manufacturer (2.2), their major version numbers (2.3) and other descriptive elements such as patch tags or software identification tags, per ISO/IEC 19770-2:2015 or SPDX 2.1 (2.4); whether the device offers a command or process to list the software components installed on it (SBOM-3); and whether a process exists for keeping the SBOM up to date (SBOM-4).

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

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