--- title: "Hardcoded Credentials, Definition | MedTech Terms" description: "Secrets - passwords, API keys, certificates - embedded in firmware or source code shipped on every device. Plain-English Cybersecurity definition for MedTech te" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/hardcoded-credentials#term", "name": "Hardcoded Credentials", "description": "Hardcoded credentials are authentication secrets - passwords, API keys, private keys, service tokens - embedded directly in firmware, binaries, or source code distributed across every unit of a device family. Because the secret is identical on every device, a single firmware extraction or source leak compromises the entire fleet. 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A single fleet-wide service password is the same vulnerability with a different label." } }, { "@type": "Question", "name": "How do we provision unique keys at scale?", "acceptedAnswer": { "@type": "Answer", "text": "Hardware secure elements (NXP A71CH, Microchip ATECC, NXP EdgeLock) come pre-provisioned with unique keys; alternatively, your manufacturing test step can generate and inject unique keys at end-of-line and record them in a key management system." } }, { "@type": "Question", "name": "Is a hashed password in firmware acceptable?", "acceptedAnswer": { "@type": "Answer", "text": "No - an attacker who extracts the firmware can crack a fleet-wide hash offline. The hash needs to be unique per device (with a per-device salt) and ideally backed by a hardware-bound key." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. Hardcoded Credentials [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) # Hardcoded Credentials Secrets - passwords, API keys, certificates - embedded in firmware or source code shipped on every device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Hardcoded credentials are authentication secrets - passwords, API keys, private keys, service tokens - embedded directly in firmware, binaries, or source code distributed across every unit of a device family. Because the secret is identical on every device, a single firmware extraction or source leak compromises the entire fleet. Hardcoded credentials have driven multiple high-profile FDA safety communications (Hospira infusion pumps, St. Jude implantables, GE imaging consoles) and remain a top finding in MedTech penetration tests. What the regulation says FDA flags hardcoded credentials as a critical cybersecurity weakness in multiple safety communications and the 2023 guidance. [CWE](/terms/cwe)\-798 (Use of Hard-coded Credentials) is one of the CWE Top 25 most dangerous software weaknesses. CISA medical-device advisories regularly cite hardcoded credentials as the root cause. Eliminating them is non-negotiable for any modern submission. ## What this means in practice Eliminating hardcoded credentials means every device must provision its own unique key material at manufacture (often via a hardware secure element), or pull a unique credential from an authenticated bootstrap service on first boot. Service accounts that need credentials should rotate them through a secrets manager rather than embedding static values. Common pitfalls - • Burning the same SSH or web-admin password into every shipped device. - • Embedding cloud API keys in mobile companion apps - they can be extracted by anyone with the app binary. - • Using a 'default password that the user must change' that, in practice, no one changes. ## Frequently asked questions What about service-mode passwords for technicians? They must be unique per device or unique per service session, generated by an authenticated key-issuance system. A single fleet-wide service password is the same vulnerability with a different label. How do we provision unique keys at scale? Is a hashed password in firmware acceptable? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity Penetration Testing Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls. ](/terms/pen-test)[ 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 Boot A chain-of-trust mechanism that ensures only cryptographically signed firmware and software can run on a device. ](/terms/secure-boot) ### More in Cybersecurity · Same category [ 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 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) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MITRE· 1 FDA· 1 CISA· 1 1. [1 CWE-798 Use of Hard-coded Credentials Verified MITRE · cwe.mitre.org ](https://cwe.mitre.org/data/definitions/798.html) 2. [2 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) 3. [3 CISA - Healthcare and Public Health Sector Verified CISA · cisa.gov ](https://www.cisa.gov/topics/critical-infrastructure-security-and-resilience/critical-infrastructure-sectors/healthcare-and-public-health-sector) 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=hardcoded-credentials) Learn in 60 seconds Card Lesson Quiz Secrets - passwords, API keys, certificates - embedded in firmware or source code shipped on every device. - · Service accounts that need credentials should rotate them through a secrets manager rather than embedding static values. - · Because the secret is identical on every device, a single firmware extraction or source leak compromises the entire fleet. - · Hardcoded credentials have driven multiple high-profile FDA safety communications (Hospira infusion pumps, St. Remember this Watch out: Burning the same SSH or web-admin password into every shipped device. Related terms - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Threat Modeling ](/terms/threat-modeling) - [Secure Boot ](/terms/secure-boot) - [Penetration Testing ](/terms/pen-test) You may also need Auto-suggested from Cybersecurity and shared keywords. - [Side-Channel Attack ](/terms/side-channel) - [Medjacking ](/terms/medjacking) - [SAST and DAST ](/terms/sast-dast) - [Code Signing ](/terms/code-signing) - [Hardware Root of Trust(HRoT) ](/terms/hardware-root-of-trust) - [Software Safety Case ](/terms/software-safety-case) [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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