--- title: "Software Safety Case, Definition | MedTech Terms" description: "A structured argument, supported by evidence, that a device's software is acceptably safe (and increasingly, secure) for its intended use." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/software-safety-case#term", "name": "Software Safety Case", "description": "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. 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FDA accepts equivalently rigorous narrative arguments. EU regulators and notified bodies sometimes prefer GSN-style structure." } }, { "@type": "Question", "name": "How does a safety case relate to ISO 14971?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 14971 produces the risk management file; the safety case argues the file's evidence supports an acceptable residual risk conclusion. They are complementary." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. Software Safety Case [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Software Safety Case A structured argument, supported by evidence, that a device's software is acceptably safe (and increasingly, secure) for its intended use. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A software safety case is a structured, documented argument - supported by traceable evidence - that a medical device's software is acceptably [safe](/terms/safe-note) in its [intended use](/terms/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 the regulation says FDA's 2023 cybersecurity guidance expects cybersecurity evidence to be integrated with safety risk evaluation under [ISO 14971](/terms/iso-14971). The combined safety-and-security case is the unifying artifact reviewers look at to assess overall residual risk. EU [MDR](/terms/mdr-reporting) Annex I §17.2 expects analogous integration. ## 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. Common pitfalls - • 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 Is a formal safety case (GSN) required? Not legally required. FDA accepts equivalently rigorous narrative arguments. EU regulators and notified bodies sometimes prefer GSN-style structure. How does a safety case relate to ISO 14971? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf)[ Cybersecurity Threat Modeling A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat. ](/terms/threat-modeling) ### More in Cybersecurity · Same category [ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ISO· 1 MDCG· 1 1. [1 FDA Cybersecurity Guidance (Sept 2023) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions) 2. [2 ISO 14971:2019 Risk Management for Medical Devices Verified ISO · iso.org ](https://www.iso.org/standard/72704.html) 3. [3 MDCG Cybersecurity Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=software-safety-case) Learn in 60 seconds Card Lesson Quiz A structured argument, supported by evidence, that a device's software is acceptably safe (and increasingly, secure) for its intended use. - · 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. - · Modern MedTech safety cases increasingly include cybersecurity arguments because exploitable vulnerabilities can produce safety harms. Remember this Watch out: Authoring the safety case after the fact - robs it of its design-influencing role. Related terms - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Secure Product Development Framework(SPDF) ](/terms/spdf) - [Threat Modeling ](/terms/threat-modeling) You may also need Auto-suggested from Cybersecurity and shared keywords. - [Secure Software Development Framework(SSDF) ](/terms/ssdf) - [Brainjacking ](/terms/brainjacking) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) - [CISA Known Exploited Vulnerabilities Catalog(KEV) ](/terms/kev) - [Common Vulnerabilities and Exposures(CVE) ](/terms/cve) - [Coordinated Vulnerability Disclosure(CVD) ](/terms/cvd) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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