OPERON ELEVATEPLUS | DESIGN HISTORY FILE
Design History File (DHF) & Medical Device Design Control Services in Brazil
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Operon ElevatePlus
Design History File (DHF) Service Portfolio
Design & Development Strategy
Define design roadmap and documentation structure
Align design controls with FDA, CE/UKCA, ISO 13485, and CDSCO requirements
Feasibility & Risk Assessment Documentation
Technical, regulatory, and market feasibility documentation
Risk management planning as per ISO 14971
Early-stage risk mitigation and regulatory alignment
Design Documentation Preparation
Design inputs, outputs, and specifications
Prototyping records and design refinement documentation
Drawings, requirements, test criteria, and engineering records
Verification & Validation (V&V) Documentation
Verification protocols, execution, and reports
Validation records including usability, clinical, and performance data
Alignment with intended use and regulatory expectations
Design Control & Change Management
Establish and document design control procedures
Design review records and approval workflows
Change control documentation with revision history
Design History File (DHF) Creation & Compilation
Complete DHF assembly covering all design phases
Inputs, outputs, V&V data, reviews, and change records
Structured, traceable, and audit-ready DHF packages
DHF Gap Assessment & Remediation
Review existing DHF and design documentation
Identify gaps against FDA 21 CFR 820.30 and ISO 13485
Corrective action planning and documentation remediation
Traceability Mapping & Design Transfer
Input–output–verification–validation traceability matrices
Design transfer documentation for manufacturing readiness
Version control and record maintenance
Regulatory Submission & Audit Support
Documentation support for FDA 510(k), PMA, CE/UKCA, CDSCO, SFDA, etc.
Preparation for FDA inspections and Notified Body audits
Guidance on audit responses and corrective actions
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
Global Consulting Presence Across US, EU, India, UK & GCC Markets
DHF & Design Documentation Aligned with FDA 21 CFR 820.30 & ISO 13485
Support for FDA 510(k), PMA, CE Marking, UKCA, CDSCO & SFDA Submissions
Decades of Combined Experience in Medical Device Design Controls
Operon Design History File Advantage
Comprehensive design & development documentation and DHF consulting to ensure regulatory compliance, traceability, and audit readiness across global medical device markets
End-to-End Design Documentation & DHF Lifecycle Support
Deep Integration with ISO 13485 & Design Control Systems
Audit-Ready, Submission-Ready Documentation Packages
Strong Traceability, Risk Management & Change Control Expertise
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frequently asked questions
What is a Design History File (DHF)?
A Design History File (DHF) is a centralized compilation of records describing the design history of a finished medical device. It contains design plans, inputs, outputs, verification/validation results, and risk management files proving the device was developed under an approved design control system.
Why is a Design History File important for ANVISA and global compliance?
A compliant DHF demonstrates that your device meets safety, essential performance, and quality requirements. Regulatory bodies like ANVISA (under RDC 665/2022), the US FDA, and notified bodies audit the DHF during inspections to ensure the device design was systematically validated prior to commercialization.
What documents are included in a Design History File?
A complete DHF includes design and development plans, user requirement specifications (URS), design inputs and outputs, risk analysis files (ISO 14971), verification and validation (V&V) test reports, design review records, and design transfer sign-offs.
Is a Design History File required for medical devices?
Yes. Design controls and DHF maintenance are mandatory for Class II, III, and IV medical devices under ANVISA BGMP, ISO 13485, and FDA 21 CFR 820.30 / QMSR frameworks.
What is the difference between a DHF, DMR, and DHR?
The DHF contains the history and validation of how the device was designed. The Device Master Record (DMR) contains the technical specifications and recipes for how to manufacture the device. The Device History Record (DHR) contains production logs proving a specific batch was built according to the DMR.