--- title: "DHF, Design History File | MedTech Terms" description: "Compilation of records describing the design history of a finished device. Plain-English Quality & Risk definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/design-history-file#term", "name": "Design History File", "alternateName": "DHF", "description": "The Design History File (DHF) contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 CFR 820.30.", "url": "https://medtechterms.com/terms/design-history-file", "termCode": "design-history-file", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/design-history-file#article", "headline": "DHF, Design History File", "description": "Compilation of records describing the design history of a finished device.", "url": "https://medtechterms.com/terms/design-history-file", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/design-history-file" }, "about": { "@id": "https://medtechterms.com/terms/design-history-file#term" }, "articleSection": "Quality & Risk", "inLanguage": "en", "keywords": "Design History File, DHF, Quality & Risk, 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": "21 CFR 820.30(j)", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "FDA - Quality Systems", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "ISO 13485 Standard Page", "url": "https://www.iso.org/iso-13485-medical-devices.html", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/design-controls#term", "name": "Design Controls", "url": "https://medtechterms.com/terms/design-controls" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-13485#term", "name": "ISO 13485", "url": "https://medtechterms.com/terms/iso-13485" } ] }, { "@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": "Quality & Risk", "item": "https://medtechterms.com/terms?cat=Quality%20%26%20Risk" }, { "@type": "ListItem", "position": 4, "name": "Design History File", "item": "https://medtechterms.com/terms/design-history-file" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/design-history-file#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of a Design History File?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose of a DHF is to provide objective evidence that the MedTech was designed and developed according to the established design control procedures and regulatory requirements, such as FDA 21 CFR 820.30." } }, { "@type": "Question", "name": "How does the DHF relate to other quality system documentation?", "acceptedAnswer": { "@type": "Answer", "text": "The DHF is closely linked to other quality system documents like the Device Master Record (DMR), which specifies how to manufacture the device, and the Device History Record (DHR), which details the manufacturing history of a specific device batch." } }, { "@type": "Question", "name": "Are electronic DHFs acceptable?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, electronic DHFs are acceptable, provided they meet the requirements for record keeping, including security, integrity, and retrievability, as outlined in regulations like 21 CFR Part 11 for electronic records." } }, { "@type": "Question", "name": "What happens if a DHF is incomplete during an audit?", "acceptedAnswer": { "@type": "Answer", "text": "An incomplete DHF can lead to regulatory non-conformances, findings during audits (e.g., FDA Form 483), and potentially impact market approval or continued market access for the MedTech." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Design History File [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)DHF # Design History File Compilation of records describing the design history of a finished device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The Design History File (DHF) contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 CFR 820.30. What the regulation says The FDA, under 21 CFR 820.30(j), mandates that each manufacturer shall establish and maintain a Design History File (DHF) for each type of MedTech. The DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements. Similarly, [ISO 13485](/terms/iso-13485):2016, in clause 7.3.10, requires that the organization shall maintain records of the results of design and development. The International Medical Device Regulators Forum ( [IMDRF](/terms/imdrf)) also emphasizes the importance of design and development documentation in their guidance on regulatory convergence. ## What this means in practice The DHF is a key inspection artifact. Under the upcoming [QMSR](/terms/qmsr), the DHF concept is harmonized with [ISO 13485](/terms/iso-13485)'s design and development records. ## Examples - A DHF might include meeting minutes from design reviews, showing discussions and decisions made during the design process for a new surgical robot. - For a software as a MedTech (SaMD), the DHF would contain software requirements specifications, architecture diagrams, and records of software testing and verification results. - A manufacturer of an implantable MedTech will have in their DHF records of biocompatibility testing, material specifications, and sterilization validation reports. Common pitfalls - • Failing to update the DHF throughout the entire product lifecycle, not just during initial development, is a common oversight. - • Including only final versions of documents and omitting interim decisions or rationale can lead to an incomplete DHF. - • Maintaining physical and electronic records in disconnected systems can make DHF retrieval and review challenging during audits. - • Not cross-referencing DHF contents effectively, making it difficult to demonstrate traceability between design inputs, outputs, verification, and validation. - • Treating the DHF as a mere paper exercise rather than a dynamic compilation of design evidence often results in critical information gaps. ## Frequently asked questions What is the primary purpose of a Design History File? The primary purpose of a DHF is to provide objective evidence that the MedTech was designed and developed according to the established design control procedures and regulatory requirements, such as FDA 21 CFR 820.30. How does the DHF relate to other quality system documentation? Are electronic DHFs acceptable? What happens if a DHF is incomplete during an audit? ## Cross-references ### Contains Sub-elements or required artefacts of this term. - [ Design Controls ](/terms/design-controls) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### QMS Foundations · From this learning path [ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. Adjacent lesson ](/terms/capa?from=qms-foundations)[ Quality & Risk Verification & Validation(V&V) Confirming design outputs meet inputs (V) and that devices meet user needs (V). Adjacent lesson ](/terms/verification-validation?from=qms-foundations)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=qms-foundations)[ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. ](/terms/form-483?from=qms-foundations) ### More in Quality & Risk · Same category [ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [QMS Foundations](/paths/qms-foundations)Lesson 6 of 10 Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 ISO· 1 1. [1 21 CFR 820.30(j) Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [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 Quality & Risk Acronym DHF Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=design-history-file) Learn in 60 seconds Card Lesson Quiz Compilation of records describing the design history of a finished device. - · The DHF is a key inspection artifact. - · Under the upcoming QMSR, the DHF concept is harmonized with ISO 13485's design and development records. Remember this Watch out: Failing to update the DHF throughout the entire product lifecycle, not just during initial development, is a common oversight. Related terms - [Design Controls ](/terms/design-controls) - [ISO 13485 ](/terms/iso-13485) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Risk Management File(RMF) ](/terms/risk-management-file) - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Device History Record(DHR) ](/terms/dhr) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.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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