We offer templates for design history files of combination products. We can perform the proper documentation for your product or we can offer templates that would help you jumpstart the work depending on your combination products. Please reach out to further discuss through the contact form.

The design and development of combination products, such as drug-device systems, must be thoroughly documented in a Design History File (DHF). The DHF is a comprehensive compilation of records that demonstrate how the product was designed, developed, and verified to meet user needs and regulatory requirements. It includes design inputs, risk assessments, design outputs, verification and validation results, and design changes. Proper documentation in the DHF ensures that every stage of the product’s development is traceable, compliant with FDA regulations and ISO standards, and ready for regulatory submission, safeguarding patient safety and product quality.

What we offer

We are experts in combination product development for injectables, including vials, prefilled syringes, accessorized prefilled syringes, autoinjectors, and wearable injectors. We offer ready to use templates for key steps of design and development to jumpstart your development.

Below are the key documents needed in Design History File. Basically the index of your DHF.

Please reach out with brief description of your combination products and which documents you need and we will get back to you.

Design History File (DHF) index:

Section 1: Planning

• Design and Development Plan (DDP)
• Human Factor Plan

Section 2: Design Inputs

• User Requirement Specification Document (URS)
• Design Input Requirements (DIR)
• Justification for specifications

Section 3: Design Output

• Formative Human Factor study
• Engineering memos
• Engineering drawingsDesign of Experiment (DOE) Studies 
• Development studies
• New Supplier Evaluations
• Engineering studies
• Device design Records(drawings, product spec, package&labeling spec..)

Section 4: Design Review and Approval

• Design review meeting minutes
• Design Freeze
• Stage gate reviews
• Management approval

Section 5: Design Verification

• Design Verification Plan
• Design Verification Protocols, Data and Reports
• Stability Protocols, Data, and Reports
• Container Closure Integrity Protocols, Data, and Reports
• Sterility Protocols, Data, and Reports
• Shipping Protocols, Data, and Reports
• Regression testing Protocols, Data, and Reports
• Biocompatibility data and Reports

6.   Design Validation

• Design Validation Master Plan
• Design Validation Protocols, data and reports (simulated use, clinical trials)
• Labeling studies
• Reliability Studies

Section 7: Design Transfer

• Process Validation Master Plan
• Reference to the processes validated for the manufacture of the product
• Reference to the Device Master Record
• Device Transfer Report

Section 8: Design Changes

• Design Change Requests including references to changes requests
• Design Change evaluations and Assessments
• Design Change Approvals

Section 9: Risk Management

• Risk Management Plan
• Medical Harm Severities
• Hazard AnalysisHarm Analysis
• UFMEA (User Failure Mode Effect Analysis)
• DFMEA (User Failure Mode Effect Analysis)
• PFMEA (Process Failure Mode Effect Analysis)
• Clinical Risk Benefit Analysis
• Additional Updates Including Outcomes for complaint Handling

Section 10: Trace matrix