Software Safety Case
A structured argument, supported by evidence, that a device's software is acceptably safe (and increasingly, secure) for its intended use.
Definition
A software safety case is a structured, documented argument - supported by traceable evidence - that a medical device's software is acceptably safe in its intended use environment. Modern MedTech safety cases increasingly include cybersecurity arguments because exploitable vulnerabilities can produce safety harms. Goal-Structuring Notation (GSN) is the most common formalism, though many MedTech teams use less formal narrative-plus-evidence structures.What this means in practice
A safety case is most useful when authored in parallel with development - claims drive what evidence the team needs to gather, evidence informs which claims can be made. Late-authored safety cases tend to be ex-post justifications rather than design drivers.- •Authoring the safety case after the fact - robs it of its design-influencing role.
- •Treating cybersecurity as a separate case from safety.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
More in Cybersecurity
· Same categoryAAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.
Primary references
3 sources- 1
FDA Cybersecurity Guidance (Sept 2023)VerifiedFDAfda.gov
- 2
ISO 14971:2019 Risk Management for Medical DevicesVerifiedISOiso.org
- 3
MDCG Cybersecurity GuidanceVerifiedMDCGhealth.ec.europa.eu
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