Design History File (DHF) Template

Medical Device Development Documentation

Document Type: Design History File
Device Name: [Insert Device Name]
Model/Part Number: [Insert Model Number]
DHF Number: [Insert DHF Number]
Version: [Insert Version]
Date: [Insert Date]

TABLE OF CONTENTS
1. DHF Overview and Administration
2. Design Controls Overview
3. Design Planning
4. Design Inputs
5. Design Outputs
6. Design Review
7. Design Verification
8. Design Validation
9. Design Transfer
10. Design Changes
11. Risk Management
12. Software Lifecycle Processes
13. Biocompatibility Assessment
14. Clinical Evaluation
15. Regulatory Documentation
16. Manufacturing Documentation
17. Labeling
18. Post-Market Surveillance
19. Document Control
20. Appendices

1. DHF OVERVIEW AND ADMINISTRATION

1.1 Device Description

Device Name: [Insert Device Name]

Classification: [Insert FDA Class I/II/III]
Regulation Number: [Insert 21 CFR section]
Product Code: [Insert FDA Product Code]
Intended Use: [Insert intended use statement]

Brief Device Description: [Provide a concise description of the device, its components, and how
it functions]

1.2 DHF Administration

DHF Owner: [Name, Title]

Document Controller: [Name, Title]
Quality Assurance Representative: [Name, Title]
Regulatory Affairs Representative: [Name, Title]

DHF Location: [Physical and/or electronic location]

Access Control: [Description of who has access and under what conditions]
Backup Procedures: [Description of backup and recovery procedures]

1.3 Document Control Matrix

Document Category Document Title Version Date Location Status

Design Plan [Title] [Version] [Date] [Location] [Status]
Design Inputs [Title] [Version] [Date] [Location] [Status]
Design Outputs [Title] [Version] [Date] [Location] [Status]
[Continue for all categories]

1.4 Regulatory Framework

Applicable Regulations:

 21 CFR 820.30 - Design Controls

 21 CFR 820.181 - Device Master Record
 ISO 13485:2016 - Quality Management Systems for Medical Devices
 ISO 14971:2019 - Risk Management for Medical Devices
 [Other applicable standards]

2. DESIGN CONTROLS OVERVIEW

2.1 Design Control Process Flow
Design Planning → Design Inputs → Design Process → Design Outputs
↓ ↓ ↓ ↓
Design Review ← Design Review ← Design Review ← Design Review
 ↓ ↓ ↓ ↓
Design Verification ← Design Verification
↓
Design Validation
↓
Design Transfer
↓
Design Changes (as needed)

2.2 Design Control Responsibilities

Role Responsibilities
Design Team Leader Overall design control implementation and coordination
Design Engineers Technical design development and documentation
Quality Assurance Design control compliance and review
Regulatory Affairs Regulatory compliance and submission preparation
Clinical Affairs Clinical evaluation and validation planning
Manufacturing Design transfer and production implementation
Risk Management Risk analysis and mitigation strategies

2.3 Design Control Procedures

Reference SOPs:

 SOP-DC-001: Design Planning

 SOP-DC-002: Design Input Management
 SOP-DC-003: Design Output Control
 SOP-DC-004: Design Review Process
 SOP-DC-005: Design Verification
 SOP-DC-006: Design Validation
 SOP-DC-007: Design Transfer
 SOP-DC-008: Design Change Control

3. DESIGN PLANNING
3.1 Design and Development Plan

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

Plan Contents:
  Project scope and objectives
 Resource allocation and responsibilities
 Timeline and milestones
 Design control activities
 Review and approval processes
 Risk management approach
 Regulatory strategy

3.2 Project Team and Organization

Project Manager: [Name, Contact]

Design Team Leader: [Name, Contact]
Team Members:

Name Department Role Contact

[Name] [Department] [Role] [Contact]
[Name] [Department] [Role] [Contact]

3.3 Project Timeline

Phase Activity Start Date End Date Responsible Status

Planning Design Planning [Date] [Date] [Name] [Status]
Input User Needs Analysis [Date] [Date] [Name] [Status]
Input Design Input Documentation [Date] [Date] [Name] [Status]
Development Concept Development [Date] [Date] [Name] [Status]
Development Design Output Creation [Date] [Date] [Name] [Status]
Verification Design Verification [Date] [Date] [Name] [Status]
Validation Design Validation [Date] [Date] [Name] [Status]
Transfer Design Transfer [Date] [Date] [Name] [Status]

3.4 Design Reviews Schedule

Review Type Planned Date Actual Date Participants Status

Design Input Review [Date] [Date] [Names] [Status]
Concept Review [Date] [Date] [Names] [Status]
Design Output Review [Date] [Date] [Names] [Status]
Verification Review [Date] [Date] [Names] [Status]
Validation Review [Date] [Date] [Names] [Status]
Final Design Review [Date] [Date] [Names] [Status]

4. DESIGN INPUTS
4.1 Design Input Summary

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

4.2 User Needs Assessment

Document Reference: [Document Number and Title]

Stakeholder Analysis:

Stakeholder
Needs/Requirements Priority Source
Group
Patients [Specific needs] [High/Medium/Low] [Interview/Survey/Literature]
Healthcare
[Specific needs] [High/Medium/Low] [Interview/Survey/Literature]
Providers
Regulatory Bodies [Requirements] [High/Medium/Low] [Regulations/Guidance]
[Economic
Payers [High/Medium/Low] [Market Research]
considerations]

4.3 Functional Requirements

Requirement Acceptance
Description Rationale Priority
ID Criteria
[Functional [Why
FR-001 [How to verify] [High/Medium/Low]
requirement] needed]
[Functional [Why
FR-002 [How to verify] [High/Medium/Low]
requirement] needed]

4.4 Performance Requirements

Requirement
Description Specification Test Method Priority
ID
[Performance [Quantitative [Test
PR-001 [High/Medium/Low]
requirement] spec] reference]
[Performance [Quantitative [Test
PR-002 [High/Medium/Low]
requirement] spec] reference]

4.5 Safety Requirements

 Requirement Risk Verification
Description Priority
ID Mitigation Method
[Safety
SR-001 [Risk control] [Test/Analysis] [High/Medium/Low]
requirement]
[Safety
SR-002 [Risk control] [Test/Analysis] [High/Medium/Low]
requirement]

4.6 Regulatory Requirements

Requirement Compliance
Description Source Priority
ID Method
[Regulatory
RR-001 [FDA/ISO/Other] [How to comply] [High/Medium/Low]
requirement]
[Regulatory
RR-002 [FDA/ISO/Other] [How to comply] [High/Medium/Low]
requirement]

4.7 Interface Requirements

Interface Type Description Requirements Standards Priority

[Interface [Specific [Applicable
User Interface [High/Medium/Low]
description] requirements] standards]
Hardware [Interface [Specific [Applicable
[High/Medium/Low]
Interface description] requirements] standards]
Software [Interface [Specific [Applicable
[High/Medium/Low]
Interface description] requirements] standards]

4.8 Environmental Requirements

Requirement Test
Description Specification Priority
ID Standard
[Environmental [Operating
ER-001 [Test method] [High/Medium/Low]
condition] range]
[Environmental [Operating
ER-002 [Test method] [High/Medium/Low]
condition] range]

4.9 Design Input Traceability Matrix

Input ID Description Source Design Output Verification Validation

[ID] [Requirement] [Source doc] [Output ref] [V&V ref] [Validation ref]

5. DESIGN OUTPUTS
5.1 Design Output Summary
Document Reference: [Document Number and Title]
Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

5.2 Design Output Categories

5.2.1 Technical Drawings and Specifications

Document Number Title Version Date Status

[Drawing No.] [Title] [Version] [Date] [Status]
[Spec No.] [Title] [Version] [Date] [Status]

5.2.2 Software Documentation

Document Number Title Version Date Status

[Doc No.] Software Requirements Specification [Version] [Date] [Status]
[Doc No.] Software Architecture Document [Version] [Date] [Status]
[Doc No.] Software Detailed Design [Version] [Date] [Status]
[Doc No.] Source Code [Version] [Date] [Status]

5.2.3 Manufacturing Documentation

Document Number Title Version Date Status

[Doc No.] Manufacturing Process Specifications [Version] [Date] [Status]
[Doc No.] Assembly Instructions [Version] [Date] [Status]
[Doc No.] Quality Control Procedures [Version] [Date] [Status]

5.2.4 Labeling and Instructions for Use

Document Number Title Version Date Status

[Doc No.] Device Labeling [Version] [Date] [Status]
[Doc No.] Instructions for Use [Version] [Date] [Status]
[Doc No.] User Manual [Version] [Date] [Status]

5.3 Design Output Completeness Checklist

 [ ] All design inputs addressed

 [ ] Design outputs are documented
 [ ] Design outputs meet design input requirements
 [ ] Design outputs contain acceptance criteria
 [ ] Design outputs reference applicable standards
 [ ] Design outputs are reviewed and approved
 [ ] Design outputs support manufacturing
  [ ] Design outputs support servicing

5.4 Design Output Traceability

Output Document Related Input(s) Verification Method Validation Method

[Output ref] [Input ID(s)] [V&V reference] [Validation reference]

6. DESIGN REVIEW
6.1 Design Review Summary

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]

6.2 Design Review Schedule and Records

Review # Review Type Date Chairperson Participants Status

DR-001 Design Input Review [Date] [Name] [Names] [Complete/Pending]
DR-002 Concept Review [Date] [Name] [Names] [Complete/Pending]
DR-003 Design Output Review [Date] [Name] [Names] [Complete/Pending]
DR-004 Verification Review [Date] [Name] [Names] [Complete/Pending]
DR-005 Validation Review [Date] [Name] [Names] [Complete/Pending]
DR-006 Final Design Review [Date] [Name] [Names] [Complete/Pending]

6.3 Design Review Documentation

For each design review, include:

 Meeting Agenda
 Attendance Record
 Presentation Materials
 Review Checklist
 Action Items and Decisions
 Meeting Minutes
 Follow-up Actions

6.4 Design Review Participants Qualifications

Participant Role Qualifications Independence

[Name] [Role] [Relevant experience/education] [Independent Y/N]

6.5 Design Review Action Items Tracking

Action ID Description Assignee Due Date Status Closure Date
DR-001-01 [Action description] [Name] [Date] [Open/Closed] [Date]

7. DESIGN VERIFICATION
7.1 Design Verification Plan

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

7.2 Verification Methods

Method Description When Used Standards

[Applicable
Testing Physical/performance testing [Test standards]
scenarios]
Mathematical/computational [Applicable
Analysis [Analysis standards]
analysis scenarios]
[Applicable [Inspection
Inspection Visual/dimensional inspection
scenarios] standards]
[Applicable
Demonstration Functional demonstration [Demo protocols]
scenarios]

7.3 Verification Test Matrix

Test Design Test Acceptance Test

Status
ID Input/Output Method Criteria Reference
VT-
[Requirement] [Method] [Criteria] [Protocol ref] [Pass/Fail/Pending]
001
VT-
[Requirement] [Method] [Criteria] [Protocol ref] [Pass/Fail/Pending]
002

7.4 Verification Test Protocols and Reports

Protocol Number Title Version Date Report Number Date Result

[Protocol No.] [Title] [Version] [Date] [Report No.] [Date] [Pass/Fail]

7.5 Test Equipment and Facilities

Equipment/Facility Description Calibration Status Location

[Equipment name] [Description] [Cal date/due date] [Location]
7.6 Verification Summary Report

Document Reference: [Document Number and Title]

Summary of Results: [Overall verification conclusion]
Non-conformances: [List any failures and resolutions]
Conclusion: [Pass/Fail determination]

8. DESIGN VALIDATION
8.1 Design Validation Plan

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

8.2 Validation Approach

Validation Strategy: [Description of overall validation approach]

User Environment: [Description of actual use conditions]
Validation Population: [Description of representative users]

8.3 Clinical Evaluation Strategy

Study Type Objective Population Duration Status

[Study type] [Objective] [n=xx, demographics] [Duration] [Status]

8.4 Validation Test Matrix

Validation User Test Acceptance Protocol

Status
ID Need Method Criteria Reference
[User
VAL-001 [Method] [Criteria] [Protocol ref] [Pass/Fail/Pending]
need]

8.5 Validation Protocols and Reports

Protocol Number Title Version Date Report Number Date Result

[Protocol No.] [Title] [Version] [Date] [Report No.] [Date] [Pass/Fail]

8.6 Validation Summary Report

Document Reference: [Document Number and Title]
Summary of Results: [Overall validation conclusion]
Clinical Evidence: [Summary of clinical data]
User Feedback: [Summary of user input]
Conclusion: [Device meets user needs confirmation]

9. DESIGN TRANSFER
9.1 Design Transfer Plan

Document Reference: [Document Number and Title]

Version: [Version Number]
Date: [Date]
Approval: [Approval signatures and dates]

9.2 Manufacturing Site Information

Primary Manufacturing Site: [Company name and address]

Additional Sites: [List any additional manufacturing locations]
Contract Manufacturers: [List any contract manufacturing arrangements]

9.3 Design Transfer Activities

Activity Description Responsible Target Date Actual Date Status

Process Development [Description] [Name] [Date] [Date] [Status]
Equipment Qualification [Description] [Name] [Date] [Date] [Status]
Process Validation [Description] [Name] [Date] [Date] [Status]
Training [Description] [Name] [Date] [Date] [Status]

9.4 Manufacturing Documentation Transfer

Document Type Document Title Manufacturing Doc Transfer Date Status

[Type] [Design document] [Manufacturing doc] [Date] [Complete/Pending]

9.5 Design Transfer Verification

Verification Method: [Description of how transfer will be verified]

Acceptance Criteria: [Criteria for successful transfer]
Verification Results: [Summary of verification activities and results]

9.6 Design Transfer Report

Document Reference: [Document Number and Title]
Transfer Summary: [Overall transfer conclusion]
Issues Identified: [Any issues and resolutions]
Conclusion: [Transfer complete/incomplete]

10. DESIGN CHANGES

10.1 Design Change Control Process

Document Reference: [Document Number and Title]

Change Control SOP: [SOP reference]

10.2 Change Request Log

Change # Description Requestor Date Reason Impact Status

DCR-001 [Description] [Name] [Date] [Reason] [High/Med/Low] [Status]

10.3 Change Impact Assessment Template

For each design change, document:

 Change Description
 Rationale for Change
 Impact on Design Inputs
 Impact on Design Outputs
 Impact on Verification/Validation
 Impact on Risk Analysis
 Regulatory Impact
 Implementation Plan

10.4 Change Implementation Records

Change Implementation Verification Validation Regulatory

Status
# Date Required Required Submission
DCR-
[Date] [Y/N] [Y/N] [Y/N] [Complete/Pending]
001

11. RISK MANAGEMENT

11.1 Risk Management Plan
Document Reference: [Document Number and Title]
Version: [Version Number]
Date: [Date]
Standard: ISO 14971:2019

11.2 Risk Management Team

Name Role Qualifications Contact

[Name] Risk Manager [Qualifications] [Contact]
[Name] Clinical Expert [Qualifications] [Contact]
[Name] Design Engineer [Qualifications] [Contact]

11.3 Risk Analysis Documentation

Document Number Title Version Date Status

[Doc No.] Preliminary Hazard Analysis [Version] [Date] [Status]
[Doc No.] Risk Analysis Report [Version] [Date] [Status]
[Doc No.] Risk Control Measures [Version] [Date] [Status]
[Doc No.] Residual Risk Evaluation [Version] [Date] [Status]
[Doc No.] Risk Management Report [Version] [Date] [Status]

11.4 Risk Control Measures Summary

Hazard Risk Control Control Type Verification Effectiveness

[Hazard] [Control measure] [Inherent/Protective/Info] [V&V reference] [Effective Y/N]

12. SOFTWARE LIFECYCLE PROCESSES

12.1 Software Classification

Software Class: [Class A/B/C per IEC 62304]

Rationale: [Justification for classification]

12.2 Software Documentation

Document Number Title Version Date Status

[Doc No.] Software Development Plan [Version] [Date] [Status]
[Doc No.] Software Requirements Specification [Version] [Date] [Status]
[Doc No.] Software Architecture Design [Version] [Date] [Status]
[Doc No.] Software Detailed Design [Version] [Date] [Status]
[Doc No.] Source Code and Documentation [Version] [Date] [Status]
[Doc No.] Software Testing Documentation [Version] [Date] [Status]
12.3 Software Development Environment

Development Tools: [List development tools and versions]

Configuration Management: [Description of version control system]
Development Standards: [Applicable coding standards]

13. BIOCOMPATIBILITY ASSESSMENT

13.1 Biocompatibility Evaluation Plan

Document Reference: [Document Number and Title]

Standard: ISO 10993 series
Classification: [Contact type and duration]

13.2 Material Characterization

Component Material Supplier Contact Type Duration

[Component] [Material] [Supplier] [Contact type] [Duration]

13.3 Biocompatibility Testing Matrix

Test ISO 10993 Part Required Rationale Status

Cytotoxicity Part 5 [Y/N] [Rationale] [Status]
Sensitization Part 10 [Y/N] [Rationale] [Status]
Irritation Part 10 [Y/N] [Rationale] [Status]
[Additional tests] [Part] [Y/N] [Rationale] [Status]

13.4 Biocompatibility Test Reports

Test Report Number Date Laboratory Result

[Test] [Report No.] [Date] [Lab name] [Pass/Fail]

14. CLINICAL EVALUATION

14.1 Clinical Evaluation Plan

Document Reference: [Document Number and Title]

Regulatory Pathway: [510(k), PMA, De Novo]
Predicate Device(s): [If applicable]
14.2 Clinical Study Information

Study ID Title Phase Sites Enrollment Duration Status

[Study ID] [Title] [Phase] [# sites] [n=xx] [Duration] [Status]

14.3 Clinical Documentation

Document Number Title Version Date Status

[Doc No.] Clinical Study Protocol [Version] [Date] [Status]
[Doc No.] Clinical Study Report [Version] [Date] [Status]
[Doc No.] Clinical Evaluation Report [Version] [Date] [Status]

15. REGULATORY DOCUMENTATION

15.1 Regulatory Strategy

Regulatory Pathway: [510(k), PMA, De Novo, Other]

Classification: [Class I/II/III]
Product Code: [FDA Product Code]
Regulation: [21 CFR section]

15.2 FDA Submission Documentation

Document Type Document Title Version Date Submission Date Status

[Type] [Title] [Version] [Date] [Date] [Status]

15.3 International Regulatory

Region Regulatory Body Submission Type Status Approval Date

EU Notified Body [Type] [Status] [Date]
Canada Health Canada [Type] [Status] [Date]
[Other] [Authority] [Type] [Status] [Date]

15.4 Regulatory Communication Log

Date Type Subject Agency Response Date Status

[Date] [Meeting/Letter] [Subject] [FDA/Other] [Date] [Status]

16. MANUFACTURING DOCUMENTATION

16.1 Device Master Record (DMR)
DMR Number: [DMR Number]
Version: [Version]
Date: [Date]

16.2 Manufacturing Process Documentation

Document Number Title Version Date Status

[Doc No.] Manufacturing Process Specification [Version] [Date] [Status]
[Doc No.] Assembly Procedures [Version] [Date] [Status]
[Doc No.] Inspection and Testing Procedures [Version] [Date] [Status]
[Doc No.] Packaging Procedures [Version] [Date] [Status]

16.3 Process Validation Documentation

Process Protocol Number Report Number Status Approval Date

[Process] [Protocol No.] [Report No.] [Status] [Date]

17. LABELING
17.1 Labeling Documentation

Document Number Title Version Date Status

[Doc No.] Device Label [Version] [Date] [Status]
[Doc No.] Instructions for Use [Version] [Date] [Status]
[Doc No.] User Manual [Version] [Date] [Status]
[Doc No.] Packaging Labels [Version] [Date] [Status]

17.2 Labeling Review Checklist

 [ ] FDA labeling requirements (21 CFR 801)

 [ ] UDI requirements (21 CFR 830)
 [ ] Instructions for use adequacy
 [ ] Warnings and precautions
 [ ] Storage and handling instructions
 [ ] Shelf life and expiration dating
 [ ] Language and readability

18. POST-MARKET SURVEILLANCE

18.1 Post-Market Surveillance Plan
Document Reference: [Document Number and Title]
Version: [Version Number]
Date: [Date]

18.2 Complaint Handling

Complaint Procedure: [SOP reference]

Medical Device Reporting: [MDR procedure reference]

18.3 Post-Market Study Requirements

Study Requirement Source Timeline Status

[Study description] [FDA/Other] [Timeline] [Status]

19. DOCUMENT CONTROL

19.1 DHF Document Control

Document Controller: [Name, Contact]

Storage Location: [Physical/Electronic location]
Access Control: [Access procedures]
Backup Procedures: [Backup description]

19.2 Document Revision History

Version Date Changed By Summary of Changes Approval

1.0 [Date] [Name] Initial release [Signature/Date]

19.3 DHF Completeness Checklist

 [ ] Design planning documentation

 [ ] Design inputs documentation
 [ ] Design outputs documentation
 [ ] Design review records
 [ ] Design verification evidence
 [ ] Design validation evidence
 [ ] Design transfer documentation
 [ ] Design change records
 [ ] Risk management file
 [ ] Software documentation (if applicable)
 [ ] Biocompatibility assessment
 [ ] Clinical evaluation
 [ ] Regulatory documentation
 [ ] Manufacturing documentation
  [ ] Labeling documentation

19.4 DHF Approval

| Role | Name