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146 Safety Risk Management for Medical Devices

minimum, Software System test records should be made available (see IEC
62304 [9] sec 5.7.5).
Note—Ensure that any Risk Controls that are implemented in the legacy
software are included in software requirements.
c. Assess the continuing validity of the available deliverables.
d. Evaluate the adequacy of existing risk management documentation vis-a `-vis
ISO 14971.

15.8 SOFTWARE OF UNKNOWN PROVENANCE

Software of Unknown Provenance or Unknown Pedigree (SOUP) refers to software
that is obtained from a third party, for which adequate documentation and records of
development process is not available. SOUP is of particular interest in areas where
software plays a pivotal role in the safety of the System.
Most medical device software uses some SOUP, as it is not practical to produce
software from scratch. So, managing the risk of SOUP becomes a fact of life.
FDA Guidance [27] states that “It may be difficult for you to obtain, generate, or
reconstruct appropriate design documentation as described in this guidance for
SOUP. Therefore, we recommend that you explain the origin of the software and the
circumstances surrounding the software documentation. Additionally, your Hazard
Analysis should encompass the risks associated with the SOUP regarding missing or
incomplete documentation or lack of documentation of prior testing. Nonetheless,
the responsibility for adequate testing of the device and for providing appropriate doc-
umentation of software test plans and results remains with you.”
IEC 62304 [9] requires that the software configuration, integration, and change
management plan include SOUP.
With respect to risk management, the functional and performance requirements of
SOUP, and hardware and software that is necessary for the proper function of SOUP
must be identified.
If failure or unexpected results from SOUP could potentially contribute to a
Hazardous Situation, at a minimum evaluate any anomaly list that is published by the
supplier of the SOUP to determine if any of the known anomalies could potentially
create a System Hazard, or lead to a Hazardous Situation.

15.9 SOFTWARE MAINTENANCE AND RISK MANAGEMENT

For most medical devices, software is continuously updated over time. The reasons
could be bug fixes, feature improvement, or cybersecurity fixes. Changes to software
can disrupt existing Risk Control measures, and/or introduce new Causes and