Key Takeaways

• A design history file is a structured compilation of records documenting how a finished medical device was developed according to an approved design plan, required by FDA under 21 CFR 820.30(j) for Class II and III devices and most Class I devices subject to design controls.
• DHF contents must include design inputs, design outputs, verification and validation records, design reviews, risk management documentation, and design transfer evidence—all maintained with full traceability back to user needs.
• The DHF differs from the device master record dmr (manufacturing specifications) and device history record dhr (batch-specific production records); together, these three record types provide complete lifecycle traceability.
• Under FDA’s Quality Management System Regulation (QMSR), effective February 2026, terminology will shift toward “medical device file,” but the core requirement for documented design history remains unchanged.
• Modern DHF management increasingly relies on eQMS and cloud-based tools to ensure audit readiness, support software as a medical device documentation, and enable efficient global regulatory submissions including EU MDR technical documentation.

What Is a Design History File (DHF)?

A design history file dhf is an organized compilation of records describing the design history of a finished device, as defined under 21 CFR 820.3(e). Think of it as the complete documentary evidence that your medical device was developed systematically, safely, and in accordance with regulatory requirements.

• The DHF demonstrates that your device was developed according to an approved design plan and design control procedures under 21 CFR 820.30
• It typically covers all development activities from concept approval through design transfer to manufacturing
• The design and development file serves as objective evidence during FDA inspections and notified body audits
• Each medical device type or model line generally requires its own DHF, though minor variants can share a DHF if justified and documented in procedures

The DHF concept aligns closely with the “design and development file” terminology used in ISO 13485:2016, particularly clauses 4.2.3 and 7.3.10. Similarly, EU MDR 2017/745 Annexes II and III require equivalent technical documentation sets covering the design and development process. Under the FDA Quality Management System Regulation (QMSR), expected to be fully applicable from February 2, 2026, the DHF will be conceptually aligned with the term “medical device file.” However, the fundamental purpose remains unchanged: providing comprehensive documentation that design controls were followed throughout medical device development.

Core Regulatory Requirements for DHF

The primary legal basis for DHF requirements in the United States is 21 CFR 820.30(j), which mandates that manufacturers establish and maintain a design history file for each type of device. Key FDA obligations include:

• Manufacturers must maintain a DHF containing or referencing all records demonstrating that the design was developed per the approved design plan
• The DHF must show evidence of compliance with all design control procedures throughout the product development process
• Records must demonstrate objective evidence for each design control element: inputs, outputs, review, verification, validation, transfer, and changes
• Documentation must be complete enough to reconstruct the design process if needed during an FDA audit

ISO 13485:2016 design and development requirements align closely:

• Design and development planning (7.3.2) must be documented with stages, responsibilities, and review points
• Design inputs (7.3.3) covering user needs, regulatory and statutory requirements, and applicable standards
• Design outputs (7.3.4) meeting input requirements and providing manufacturing information
• Design reviews (7.3.5) at suitable stages with documented results and follow-up actions
• Design verification (7.3.6) confirming outputs meet inputs
• Design validation (7.3.7) ensuring the device meets user needs and intended use
• Design transfer (7.3.8) ensuring production specifications match validated design
• Design changes (7.3.9) with impact analysis and re-verification where needed

Regulators expect all DHF content to be legible, dated, approved by authorized personnel, and controlled under document procedures. Under 21 CFR 820.180(b), records must be retained for the life of the device plus at least two years—a requirement that underscores the importance of proper documentation and storage location management.

What Belongs in a DHF? (Typical Contents)

While no mandated template exists for DHF structure, certain categories of records are consistently expected during regulatory inspections. Your DHF index should reflect these key elements clearly, allowing auditors to navigate the design documentation efficiently. Essential DHF content categories:

• Design and development plan: The roadmap for your entire design process, including stages, milestones, resources, and responsibilities
• User needs and intended use: Voice-of-customer documentation, clinician interviews, and clear statements of the device’s medical purpose
• Design inputs: Measurable engineering specifications derived from user needs, regulatory requirements, and applicable standards
• Risk management documentation: Hazard analyses, risk assessments, and mitigation strategies per ISO 14971
• Design outputs: CAD drawings, software requirements specifications, BOMs, labeling artwork, and device specifications
• Design review records: Meeting minutes, attendance logs, decisions, and action item closures from formal review milestones
• Verification reports: Test protocols, raw data, and summary reports demonstrating outputs meet inputs
• Validation reports: Clinical evaluations, usability studies, and simulated-use testing confirming the device meets user needs
• Design transfer documentation: Checklists, pilot build reports, and production specifications handover records
• Design change history: Engineering change orders, impact assessments, and re-verification evidence

Real-world example for a Class II infusion pump (2022-2024 development):

Content Category	Example Documents
User needs	Voice-of-customer reports from Q1 2023, clinician interview summaries, market requirements specification
Design inputs	System Requirements Specification SRS-001 Rev. B, IEC 60601-1-2 EMC requirements matrix
Design outputs	Mechanical CAD package Rev. D, embedded software build v2.3.1, labeling artwork LBL-001
Verification	IEC 60601-1 electrical safety test report, cybersecurity penetration test results
Validation	Summative usability study report from Q2 2024, clinical performance evaluation

Remember that the DHF can “contain or reference” documents. Many medical device companies maintain an index pointing to controlled records in their quality management system repository rather than duplicating every document within the DHF itself.

Phases of the Design Control Process

Most medical device projects follow a staged design control model that maps directly to FDA and ISO requirements. Understanding these phases helps your development team generate the right DHF records at the right time, ensuring regulatory compliance from day one. Design and Development Planning (21 CFR 820.30(a), ISO 7.3.2) This initial phase establishes the overall design plan, defining stages, responsibilities, review points, and interfaces between different groups. DHF records typically include the signed design plan, Gantt charts, and resource allocation documents. For example, a project might kick off in January 2023 with an initial design plan approved, establishing verification completion targets for March 2024. User Needs Gathering (21 CFR 820.30(c), ISO 7.3.2-7.3.3) During this phase, the design team captures requirements from clinicians, patients, and internal stakeholders. DHF records include interview notes, survey results, complaint trend analyses, and the formal user needs specification. This phase might produce a comprehensive user needs document by February 2023. Design Inputs Development (21 CFR 820.30(c), ISO 7.3.3) User needs are translated into measurable engineering and software specifications. The DHF captures the approved design inputs document, traceability to user needs, and acceptance criteria. A typical milestone would be design input approval in April 2023, triggering the first design review. Design Outputs Creation (21 CFR 820.30(d), ISO 7.3.4) The design team develops detailed solutions meeting the inputs. DHF records include production process specifications, drawings, software architecture documents, and verification plans. Design outputs might reach initial completion by September 2023. Design Review Milestones (21 CFR 820.30(e), ISO 7.3.5) Formal reviews occur at key phase gates—for example, a first design review in June 2023 and a design freeze review in October 2023. The DHF must contain review minutes, attendance logs showing independent reviewers, and evidence of action item closure. Design Verification (21 CFR 820.30(f), ISO 7.3.6) This phase generates objective evidence that outputs meet inputs through testing, inspection, and engineering analysis. DHF records include test protocols, raw data, and summary reports. Verification completion might occur in March 2024 for a typical development program. Design Validation (21 CFR 820.30(g), ISO 7.3.7) Validation confirms the device meets user needs under actual or simulated use conditions. DHF records include usability studies, clinical evaluations, and validation testing reports. For our example timeline, summative validation might complete in Q3 2024. medical devices Design Transfer (21 CFR 820.30(h), ISO 7.3.8) The final pre-production phase ensures the verified and validated design is correctly translated into manufacturing specifications. DHF records include transfer checklists, pilot build reports, and process validation protocols.

Detailed Components of the DHF

This section breaks down each critical DHF component using a realistic example: a reusable Class II orthopedic surgical instrument developed between 2022 and 2024. Each subsection illustrates the type of proper documentation your DHF should contain or reference.

Design and Development Plan

The design and development planning document serves as your roadmap for the entire device design lifecycle, from initial concept through design transfer to manufacturing.

• The plan defines stages (feasibility, design, verification, validation, transfer), each with clear entry and exit criteria
• Responsibilities are assigned to specific roles: project manager, lead engineer, regulatory affairs, quality assurance procedures owner
• Review points are scheduled at major milestones, typically aligned with phase gate decisions
• Resource allocation matrices identify personnel, equipment, and budget for each phase
• Risk-based planning references ISO 14971, ensuring hazard identification activities are scheduled appropriately

For our orthopedic instrument example, the initial design plan (Rev. A) was approved in March 2022. A plan revision (Rev. C) was issued in August 2023 to extend verification activities after additional IEC 60601-1 testing requirements were identified. This revision is documented in the DHF with change rationale, approval signatures, and updated timeline. The design plan should be version-controlled with clear revision history, and each revision should be traceable to the triggering event—whether a scope change, risk finding, or regulatory update.

User Needs and Intended Use

User needs documentation captures the “voice of the customer” that drives all subsequent design activities. These records form the foundation of your requirements traceability matrix.

• Voice-of-customer interviews with orthopedic surgeons documented key handling requirements: instrument weight under 200g, ergonomic grip angle, and resistance to repeated sterilization cycles
• Field observations at three hospital surgical suites in Q1 2023 identified the need for single-handed operation during minimally invasive procedures
• Complaint trend analysis from predecessor devices highlighted durability issues that informed new material requirements
• The intended use statement clearly defines the medical purpose: “mechanical manipulation and positioning of bone fragments during orthopedic surgery in adult patients”
• Target markets (US, EU, Canada) are specified, driving applicable regulatory standards

All user needs documents should be traceable to design inputs via the requirements traceability matrix, which is referenced in the DHF index. This traceability enables efficient design verification and supports regulatory submissions.

Design Inputs

Design inputs translate user needs and regulatory requirements into measurable, testable specifications that guide the design and development activities.

• User needs are decomposed into specific engineering requirements with acceptance criteria
• Applicable standards are identified and incorporated: IEC 60601-1 (where applicable), ISO 13485, sterilization standards per ISO 17665
• Regulatory guidance documents inform requirements, such as FDA guidance on reprocessing reusable medical devices
• The System Requirements Specification (SRS-001 Rev. B, approved April 2023) contains all design inputs with unique identifiers for traceability
• Each input includes a defined verification method (test, analysis, inspection, or demonstration)

For software components, inputs include software requirements specifications referencing IEC 62304 software lifecycle requirements. All inputs are controlled via change management, with modifications requiring impact assessment and re-approval before implementation. Clear, complete design inputs with measurable acceptance criteria are essential—they directly enable effective design verification later in the process, starting from medical device prototyping.

Design Outputs

Design outputs constitute the detailed description of the final design solution and form the basis of the device master record used for manufacturing.

• Mechanical design outputs: CAD drawings (DWG-001 through DWG-045), assembly specifications, material specifications (titanium alloy per ASTM F136)
• Manufacturing outputs: Process flow diagrams, work instructions, installation specifications for production equipment
• Software outputs: Embedded firmware binary v1.2.0, source code repository reference, build instructions
• Labeling outputs: Labeling artwork (LBL-001 Rev. C), Instructions for Use (IFU-001), sterilization indicators
• Bill of materials with approved suppliers and component specifications

Each output must demonstrably satisfy one or more design inputs through bi-directional traceability captured in the DHF. Output documents include revision levels, approval signatures, and effective dates. Outputs must be formally reviewed and approved before design transfer, with evidence of these approvals stored or referenced in the DHF.

Design Review Records

Design reviews are formal milestones where cross-functional teams evaluate design progress, identify issues, and authorize advancement to subsequent design stages.

• System Requirements Review (March 2023): Confirmed design inputs were complete, traceable to user needs, and technically feasible
• Preliminary Design Review (July 2023): Evaluated design concepts against inputs, identified three open risks requiring mitigation
• Critical Design Review (October 2023): Froze design outputs, approved verification protocols, authorized verification testing
• Design Transfer Review (August 2024): Confirmed all verification and validation testing complete, approved transition to manufacturing

Each review record includes the agenda, list of attendees (including at least one independent reviewer per 21 CFR 820.30(e)), presentation materials, key decisions, and action item logs. The DHF references these records with document numbers and dates. Action items are tracked to closure before phase advancement. For example, a decision during the October 2023 review to add cybersecurity penetration testing (prompted by a 2022 industry recall of a networked device) was documented as action item CDR-017, with closure evidence referenced in the DHF.

Design Verification

Design verification provides objective evidence that design outputs meet design inputs through testing, inspection, and analysis.

• Environmental stress testing (January-February 2024) verified performance under defined operating conditions per IEC 60601-1-2 electromagnetic compatibility requirements
• Mechanical fatigue testing confirmed the instrument handle withstands 10,000 actuation cycles without degradation
• Biocompatibility testing per ISO 10993 verified material safety for extended tissue contact
• Software verification included unit testing, integration testing, and code review per IEC 62304

DHF verification records include:

• Protocols with pre-defined acceptance criteria linked to specific design inputs
• Raw data files or references to data repositories
• Test reports summarizing results against acceptance criteria
• Deviation and nonconformance reports with disposition decisions
• Traceability matrix entries linking each verification activity to input requirements

The DHF must demonstrate complete traceability—every design input should have corresponding verification evidence showing it was met.

Design Validation

Design validation confirms the final device meets user needs and intended use under actual or simulated use conditions. Unlike verification, which tests against specifications, validation testing answers: “Did we build the right device?”

• Formative usability study (November 2023): Ten orthopedic surgeons evaluated prototype handling during simulated procedures, identifying grip modifications
• Summative human factors validation (June 2024): Twenty-five users representing the target population completed use scenarios with production-equivalent devices per IEC 62366-1
• Clinical performance evaluation: Bench testing demonstrating performance criteria alignment with clinical expectations

Validation records include:

• Protocols describing test methods, success criteria, and participant selection, often prepared by a product design engineer
• IRB approvals where applicable (referenced, not reproduced in DHF)
• Signed informed consent documentation references
• Test reports with statistical analysis and conclusions
• Device configuration records showing exact software versions and hardware revisions used

Validation testing must use production-equivalent devices and final packaging to ensure results reflect the commercial product. The DHF clearly documents device serial numbers, software versions, and manufacturing dates for all validation testing units, including initial production units where applicable.

Design Transfer

Design transfer is the controlled handover from R&D to manufacturing, ensuring that production specifications correctly reflect the approved design outputs.

• Transfer checklist (TRF-001) documents verification of all manufacturing documentation completeness
• Pilot build reports from June 2024 demonstrate manufacturability and identify process optimization opportunities
• Process Failure Mode and Effects Analysis (PFMEA) approved in July 2024
• Process validation protocols approved under 21 CFR 820.75
• Training records document qualification of production personnel on new manufacturing process requirements

The DHF references the creation or update of the device master record, ensuring alignment between validated design outputs and manufacturing specifications. Training materials used to qualify production staff are also referenced. Effective design transfer reduces the risk of discrepancies between the verified and validated design and the manufactured product—a common source of quality issues and regulatory findings.

Design Changes and Iterations

Design changes occur throughout development and after commercial release. All pre-market design changes belong in the DHF with clear rationale and impact analysis.

• A Q4 2023 design change increased handle diameter based on usability feedback, documented via Engineering Change Order ECO-2023-047
• A 2025 software patch addressed a cybersecurity vulnerability, with updated risk assessment per ISO 14971 and regression testing evidence
• Each change record includes: change description, rationale, impact analysis, affected documents, verification activities required, and approval signatures

Post-market design changes are typically documented through DMR updates, but the DHF should reference the design change control strategy and link to the post-market design history. Design changes connect to other quality system elements: complaint data may trigger changes, CAPA records may mandate design modifications, and updated verification or validation testing may be required. The DHF maintains cross-references to these related records, ensuring comprehensive documentation of the complete design process.

DHF vs. DMR vs. DHR (and the Future “Medical Device File”)

Understanding the distinction between DHF, DMR, and DHR is essential for lifecycle documentation management. These three record types work together to ensure complete traceability from design intent through manufacturing execution. Design History File (DHF): The DHF documents how the device was designed and developed. It contains or references all records demonstrating that design controls were followed, from user needs through design transfer. The DHF answers: “How was this device designed?” Device Master Record (DMR): Defined under 21 CFR 820.181, the DMR contains the “recipe” for manufacturing the device—production specifications, quality assurance procedures, packaging and labeling specifications, and installation and service procedures. The DMR answers: “How do we make this device?” Device History Record (DHR): Defined under 21 CFR 820.184, the DHR is the batch or lot-specific record of production. It includes manufacturing dates, quantities, acceptance records, labeling, and the unique device identifier. The DHR answers: “How was this specific unit made?” Traceability example—cardiac catheter labeling: Consider a labeling content requirement for a cardiac catheter:

1. DHF: Contains the design input specifying required labeling elements per FDA regulations, user needs for clear sizing indicators, and validation testing confirming label legibility under clinical lighting conditions
2. DMR: Contains the approved labeling artwork (LBL-001 Rev. D), printing specifications, and incoming inspection criteria for label materials
3. DHR: Contains inspection records confirming labels applied to lot 2024-0892 passed visual inspection, with label samples retained per procedures

This flow ensures that any manufactured device can be traced back through its production record (DHR), to the specifications that governed its manufacture (DMR), to the design rationale that established those specifications (DHF). FDA QMSR and the “Medical Device File” terminology: The upcoming FDA Quality Management System Regulation aligns U.S. requirements more closely with ISO 13485:2016. Under QMSR, terminology shifts toward “medical device file” as a more encompassing concept. In practice, companies may maintain a combined or cross-referenced structure while preserving distinct DHF, DMR, and DHR concepts for operational clarity. The key principle remains unchanged: comprehensive documentation enabling bidirectional traceability throughout the device lifecycle.

Managing DHF Documentation in Practice

Effective DHF management is one of the most challenging aspects of medical device development. Common pain points include scattered documents across multiple systems, uncontrolled spreadsheets serving as traceability matrices, incomplete records discovered during audits, and difficulty demonstrating design history to inspectors. Building and maintaining your DHF:

1. Create a DHF index: Establish a master document listing all DHF contents with document numbers, titles, revision levels, owners, and storage location references
2. Define ownership: Assign a DHF owner (typically the project manager or design team lead) responsible for index maintenance and completeness
3. Use standardized naming conventions: Consistent naming enables efficient retrieval and reduces filing errors
4. Apply document control: All DHF documents must be controlled per quality system procedures—reviewed, approved, revision-controlled, and change-managed
5. Conduct periodic internal audits: Review DHF completeness before major milestones (design reviews, submission preparation, annual assessments)

Practical example from a 2022-2024 device project: A medical device company developing a Class II diagnostic device conducted DHF gap assessments at three points:

• Before design freeze (October 2023): Identified missing traceability links for 12 requirements, remediated before verification
• Before 510(k) submission (March 2024): Confirmed all verification and validation records complete and cross-referenced
• Before EU MDR technical documentation update (September 2024): Verified alignment between DHF and EU-required documentation

Digital tools for DHF management: Modern eQMS and cloud-based design control platforms offer significant advantages:

• Centralized artifact storage with automatic version control
• Real-time traceability matrix updates
• Audit trail documentation for all changes
• Remote access for distributed development teams
• Efficient retrieval during regulatory inspections

While paper-based systems remain acceptable if controls are robust, digital tools substantially reduce the effort needed to maintain procedures, respond to FDA Form 483 observations, or address EU nonconformity reports related to design documentation.

DHF Considerations for Software and SaMD

Software in medical devices and standalone Software as a Medical Device (SaMD) have additional documentation expectations that must be integrated into your DHF. IEC 62304 (Medical Device Software Lifecycle) and FDA software guidance establish specific requirements beyond traditional hardware design controls. Mapping traditional DHF elements to software artifacts:

DHF Element	Software Equivalent
Design inputs	Software requirements specifications, system architecture requirements
Design outputs	Software architecture documents, detailed design documents, source code
Verification	Unit testing, integration testing, code reviews, static analysis
Validation	System testing, usability testing, clinical validation
Design review	Software milestone reviews, architecture reviews
Design transfer	Build verification, deployment procedures, release notes

Key DHF entries for software:

• Software risk classification (Level of Concern per FDA guidance or IEC 62304 safety classification)
• Software development lifecycle documentation
• Cybersecurity risk assessments and threat modeling
• Secure development lifecycle evidence
• Software Bill of Materials (SBOM)
• Regression testing records for each release

Example: Mobile app for remote patient monitoring (launched 2024) A SaMD mobile application for remote cardiac monitoring included these DHF entries:

• Software Requirements Specification (SRS-MOB-001 Rev. C)
• System architecture diagrams showing app-cloud-clinical interface relationships
• API specifications for data exchange with hospital EHR systems
• Penetration test reports from an independent security firm (March 2024)
• IEC 62304 software lifecycle documentation
• Revision history logs documenting all software changes from v1.0 through v1.3

For devices containing both hardware and software, the DHF must integrate both streams into one coherent design history. Requirements traceability matrices should link hardware and software elements to system-level user needs, ensuring end-to-end traceability across disciplines. Maintain procedures for continuous deployment environments, documenting how software updates are controlled, validated, and traced within the DHF structure.

Using Images and Visual Aids in DHF Guidance

Visual aids significantly enhance understanding of DHF structure and processes. When developing internal training materials or procedures, consider including: Image 1 – Design Control Flow Diagram: A flowchart showing the progression from user needs through design inputs, outputs, verification, validation, and transfer. This visual should appear near discussions of design control phases, helping readers understand how records accumulate through the development lifecycle. Image 2 – DHF-DMR-DHR Relationship Schematic: A diagram illustrating information flow between these three record types over the product lifecycle. This graphic clarifies how design decisions in the DHF become manufacturing specifications in the DMR and are verified through individual DHRs. Image 3 – Sample DHF Index Layout: A mock-up showing document IDs, titles, revision levels, owners, and status columns. This practical example helps teams structure their own DHF indexes effectively. Each visual should include descriptive alt text (e.g., “Diagram showing traceability from DHF to DMR and DHR”) and be referenced in surrounding text to clarify its purpose for readers.

Preparing Your DHF for Regulatory Audits

FDA inspections and EU MDR audits between 2023 and 2025 have increasingly focused on design control documentation. Incomplete DHFs remain one of the most frequent sources of regulatory findings, making audit preparation essential. Best practices for audit readiness:

• Conduct pre-audit gap assessments: Review DHF completeness 4-6 weeks before scheduled inspections
• Verify traceability matrix completeness: Confirm every design input has verification evidence and every user need has validation evidence
• Check signatures and dates: Ensure all approvals are complete with legible signatures and dates
• Train subject-matter experts: Prepare key personnel to walk auditors through the DHF structure and answer questions confidently
• Organize storage location references: Ensure all referenced documents can be retrieved within minutes

Create a DHF summary document: Consider developing a brief “DHF map” that guides auditors to key records related to Design for Manufacture:

• Index of design control phases with document references
• Quick-reference traceability showing input-to-verification linkages
• Summary of validation testing and outcomes
• Change history overview

This summary should itself be controlled and referenced in the DHF. Example audit questions and responses:

Auditor Question	DHF-Enabled Response
“Show how you validated the device for home use in elderly patients.”	Reference summative usability study protocol and report, participant demographics, and validation conclusions
“How did you verify electromagnetic compatibility?”	Reference IEC 60601-1-2 test protocol, test facility accreditation, test report, and traceability to design input
“What changed between Rev. A and Rev. C of the design?”	Reference engineering change orders, impact assessments, and re-verification records

After audits, any DHF-related findings should feed into CAPA processes. DHF updates addressing these findings must be documented and cross-referenced to CAPA records, demonstrating continuous improvement per the quality management system.

FAQ – Design History File (DHF)

Do I need a separate DHF for every device variant? Not necessarily. Many medical device companies use family-based DHFs where device variants sharing the same fundamental design and manufacturing process are documented together. This approach is acceptable when variants differ only in size, color, or minor features that don’t affect safety or performance. However, you must document and justify this approach in your procedures, and the DHF must clearly identify which verification and validation testing applies to each variant. Regulatory expectations favor separate DHFs when design differences could impact risk profiles or require distinct verification methods. How long must I keep DHF records? Under 21 CFR 820.180(b), manufacturers must retain DHF records for the expected life of the device plus at least two years. For devices with indefinite lifecycles (like reusable surgical instruments), records must be maintained as long as the device is in distribution. EU MDR requirements may extend retention periods based on device risk class—implantable devices typically require records for at least 15 years after the last device is placed on the market. Establish clear retention policies in your quality management system and ensure your storage location infrastructure supports long-term preservation. Can legacy devices be remediated if we never built a formal DHF? Yes, remediation is possible and often necessary for safe medical devices brought to market before current regulations. The approach involves reconstructing design history from existing documents—engineering notebooks, test reports, manufacturing records, and complaint data. Perform a retrospective risk assessment per ISO 14971 to identify and address any hazards not previously documented. Document gaps transparently, noting which design control elements cannot be fully reconstructed and why this is acceptable based on device history and current risk profile. This remediated DHF should be maintained going forward as the design history. What tools are acceptable for managing DHF—can we still use paper? Paper-based DHF systems remain acceptable under FDA regulations if robust document control is maintained. However, paper systems face significant challenges: difficulty with version control, inefficient retrieval during audits, storage space requirements, and risks of loss or damage. Regulators increasingly expect efficient retrieval and comprehensive version control, which digital tools provide more reliably. eQMS platforms offer advantages including automatic audit trails, real-time traceability updates, remote access for distributed teams, and simplified backup procedures. Most medical device companies transitioning to ISO 13485:2016 and preparing for QMSR are adopting digital solutions. How does DHF documentation differ for software-only (SaMD) products? SaMD DHFs include additional expectations beyond traditional hardware design controls. You must document the complete software lifecycle per IEC 62304, including software requirements specifications, architecture design, code implementation records, and all testing levels from unit through system testing. Cybersecurity risk assessments and secure development lifecycle documentation are essential, not optional. For products using continuous deployment, document your change control process showing how updates are verified, validated, and traced. Unlike hardware, software changes may be frequent—your DHF structure must accommodate rapid iteration while maintaining complete traceability from user needs through code-level artifacts.

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Building and maintaining a comprehensive design history file isn’t just about checking regulatory boxes—it’s about creating a clear record of thoughtful, systematic device development that protects patients and your business. Whether you’re launching your first medical device or managing a portfolio of products, strong DHF practices reduce audit stress, accelerate regulatory submissions, and demonstrate your commitment to quality. Start by assessing your current DHF practices against the key fda requirements outlined in this guide. Identify gaps, prioritize remediation, and consider implementing digital tools to streamline your design documentation. Your future self—and your regulatory affairs team—will thank you.