--- title: "Penetration Testing, Definition | MedTech Terms" description: "Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pen-test#term", "name": "Penetration Testing", "alternateName": [ "Pen test", "Pentest" ], "description": "Penetration testing (pen testing) is hands-on adversarial security testing in which qualified, sufficiently independent testers attempt to exploit a medical device's security controls - network services, web/API interfaces, wireless protocols, physical interfaces (USB, JTAG, UART), companion apps, and back-end cloud - to uncover weaknesses that automated scanners miss. A pen test produces an evidence package: methodology, findings (with reproduction steps), severity ratings, and remediation recommendations.", "url": "https://medtechterms.com/terms/pen-test", "termCode": "pen-test", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/pen-test#article", "headline": "Penetration Testing", "description": "Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls.", "url": "https://medtechterms.com/terms/pen-test", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/pen-test" }, "about": { "@id": "https://medtechterms.com/terms/pen-test#term" }, "articleSection": "Cybersecurity", "inLanguage": "en", "keywords": "Penetration Testing, Pen test, Pentest, Cybersecurity, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA Cybersecurity Guidance (Sept 2023)", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "NIST SP 800-115 Technical Guide to Information Security Testing", "url": "https://csrc.nist.gov/publications/detail/sp/800-115/final", "publisher": { "@type": "Organization", "name": "NIST" } }, { "@type": "CreativeWork", "name": "HSCC - Health Sector Coordinating Council", "url": "https://healthsectorcouncil.org/", "publisher": { "@type": "Organization", "name": "HSCC" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sast-dast#term", "name": "SAST and DAST", "url": "https://medtechterms.com/terms/sast-dast" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/premarket-cybersecurity#term", "name": "Premarket Cybersecurity Submission", "url": "https://medtechterms.com/terms/premarket-cybersecurity" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/section-524b#term", "name": "Section 524B of the FD&C Act", "alternateName": "524B", "url": "https://medtechterms.com/terms/section-524b" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/aami-tir57#term", "name": "AAMI TIR57", "url": "https://medtechterms.com/terms/aami-tir57" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/threat-modeling#term", "name": "Threat Modeling", "url": "https://medtechterms.com/terms/threat-modeling" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/spdf#term", "name": "Secure Product Development Framework", "alternateName": "SPDF", "url": "https://medtechterms.com/terms/spdf" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Cybersecurity", "item": "https://medtechterms.com/terms?cat=Cybersecurity" }, { "@type": "ListItem", "position": 4, "name": "Penetration Testing", "item": "https://medtechterms.com/terms/pen-test" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/pen-test#faq", "mainEntity": [ { "@type": "Question", "name": "How independent do testers need to be?", "acceptedAnswer": { "@type": "Answer", "text": "FDA expects 'sufficient independence' - practically, that means testers who did not author the code under test. External firms or an internal red team that reports outside the product engineering line both qualify." } }, { "@type": "Question", "name": "How often should we pen-test?", "acceptedAnswer": { "@type": "Answer", "text": "At minimum: before initial submission, after any significant security-relevant change, and on an annual cadence post-launch. High-risk devices may warrant more frequent or continuous testing." } }, { "@type": "Question", "name": "Is automated scanning enough?", "acceptedAnswer": { "@type": "Answer", "text": "No. Automated SAST/DAST/SCA tools are necessary but find only known-pattern issues. Penetration testing exercises business-logic flaws, design weaknesses, and chained exploits that scanners cannot." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. Penetration Testing [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) # Penetration Testing Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Penetration testing (pen testing) is hands-on adversarial security testing in which qualified, sufficiently independent testers attempt to exploit a medical device's security controls - network services, web/API interfaces, wireless protocols, physical interfaces (USB, JTAG, UART), companion apps, and back-end cloud - to uncover weaknesses that automated scanners miss. A pen test produces an evidence package: methodology, findings (with reproduction steps), severity ratings, and remediation recommendations. What the regulation says FDA's 2023 guidance explicitly expects penetration testing for cyber-device submissions, performed by personnel with sufficient independence from the development team. The submission should describe the testing scope, qualifications of the testers, methodology (e.g., NIST SP 800-115, OWASP MASTG/WSTG), and how findings were addressed. [AAMI TIR57](/terms/aami-tir57) and [IEC 81001-5-1](/terms/iec-81001-5-1) also reference penetration testing as a lifecycle activity. ## What this means in practice Pen testing is most valuable when scoped against a current threat model and run before [V&V](/terms/verification-validation) freeze so findings can be designed-out rather than risk-accepted. Mature MedTech teams budget for an annual external pen test plus targeted retests after major changes. Findings flow into [CAPA](/terms/capa) and re-test verification. Common pitfalls - • Hiring a generic pen-test firm with no medical-device experience - they'll miss the device-specific attack surface. - • Scoping the test too narrowly (only the web UI) and missing the wireless, hardware, or backend channels. - • Treating the pen-test report as a one-time deliverable instead of feeding remediation into CAPA and re-test. ## Frequently asked questions How independent do testers need to be? FDA expects 'sufficient independence' - practically, that means testers who did not author the code under test. External firms or an internal red team that reports outside the product engineering line both qualify. How often should we pen-test? Is automated scanning enough? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ 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 SAST and DAST Automated security testing - SAST analyzes source code at rest, DAST exercises a running application. ](/terms/sast-dast)[ 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) ### More in Cybersecurity · Same category [ 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)[ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ 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) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Mentioned in recent activity 1 entry FDA 510(k) (1) [Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260754) Assure Tech., LLC · 2026-06-05 ## Latest in MedTech [View all](/latest?term=pen-test) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - 510(k) 2026-06-05 [Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260754) Assure Tech., LLC ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 NIST· 1 HSCC· 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 NIST SP 800-115 Technical Guide to Information Security Testing Verified NIST · csrc.nist.gov ](https://csrc.nist.gov/publications/detail/sp/800-115/final) 3. [3 HSCC - Health Sector Coordinating Council Verified HSCC · healthsectorcouncil.org ](https://healthsectorcouncil.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Penetration testing for a connected device? We perform medical-device-specific penetration testing aligned to FDA premarket guidance and AAMI TIR57. [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=pen-test) Learn in 60 seconds Card Lesson Quiz Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls. - · Pen testing is most valuable when scoped against a current threat model and run before V&V freeze so findings can be designed-out rather than risk-accepted. - · Mature MedTech teams budget for an annual external pen test plus targeted retests after major changes. - · Findings flow into CAPA and re-test verification. Remember this Watch out: Hiring a generic pen-test firm with no medical-device experience - they'll miss the device-specific attack surface. Related terms - [SAST and DAST ](/terms/sast-dast) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [AAMI TIR57 ](/terms/aami-tir57) - [Threat Modeling ](/terms/threat-modeling) - [Secure Product Development Framework(SPDF) ](/terms/spdf) You may also need Auto-suggested from Cybersecurity and shared keywords. - [OWASP IoT and Embedded Application Security ](/terms/owasp-iot) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [SOC 2 ](/terms/soc-2) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) - [HIPAA(HIPAA) ](/terms/hipaa) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)