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.Examples
- A team developing an insulin pump's software submitted a safety case detailing how fault-tolerant coding practices and robust input validation prevent overdose risks, supported by testing logs and code reviews.
- For a new surgical robot, the safety case presented arguments that its software controls were immune to common network-based attacks that could lead to unintended movements, referencing penetration test results and threat models.
- A MedTech company updated its pacemaker software safety case to include new evidence of secure boot mechanisms and encrypted firmware updates, addressing potential tampering vulnerabilities identified during post-market surveillance.
- •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.
Where this term appears across MedTech Terms.
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA Cybersecurity Guidance (Sept 2023)Tier 2 VerifiedFDAfda.gov
- 2ISO 14971:2019 Risk Management for Medical DevicesTier 1 VerifiedISOiso.org
- 3MDCG Cybersecurity GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.