Comprehensive Guide to Managing Design History Files (DHF) in Medical Device Manufacturing

1) Purpose

The purpose of this SOP is to define a structured approach for creating, maintaining, and managing Design History Files (DHF) for medical devices. The DHF ensures that all design and development activities comply with regulatory requirements, demonstrating the device’s conformity to design controls.

2) Scope

This SOP applies to the management of DHFs for all medical devices developed within the organization. It is relevant to personnel involved in design and development, quality assurance, regulatory affairs, and project management.

3) Responsibilities

– Design and Development Team: Provides design inputs, outputs, and validation data for inclusion in the DHF.
– Quality Assurance (QA): Reviews and approves DHF documents for accuracy and compliance.
– Regulatory Affairs: Ensures DHF documentation meets applicable regulatory requirements.
– Document Control Team: Manages version control, access, and secure storage of DHF records.
– Project Manager: Oversees the timely completion of design control activities and ensures DHF completeness.

4) Procedure

4.1 Establishing the DHF Framework
4.1.1 Defining DHF Contents
– Include the following in the DHF:
– Design and development plan
– Design inputs
– Design outputs
– Design review records
– Design verification and validation data
– Risk management documentation
– Change control records
– Any other records demonstrating compliance with design controls.

4.1.2 Document Templates
– Use standardized templates for all DHF documents, such as design input forms, review minutes, and test reports.
– Ensure templates include required fields for traceability, such as document ID, revision number, and approval signatures.

4.1.3 Approval Workflow
– Establish an approval workflow for each DHF document, ensuring review and sign-off by relevant stakeholders (e.g., QA, regulatory, and design leads).

4.2 Creating the DHF
4.2.1 Design and Development Plan
– Develop a Design and Development Plan detailing:
– Project scope and objectives.
– Timelines and milestones.
– Responsibilities and resources.
– Include the plan as the first document in the DHF.

4.2.2 Design Inputs
– Collect design inputs from user needs, regulatory requirements, risk analysis, and industry standards.
– Document inputs in the Design Input Specification Form and ensure traceability to design outputs.

4.2.3 Design Outputs
– Document design outputs that meet design input requirements, such as engineering drawings, manufacturing specifications, and software codes.
– Verify that outputs are complete, accurate, and capable of being tested.

4.2.4 Design Reviews
– Conduct design reviews at defined milestones, such as concept approval, preliminary design, and final design.
– Record review findings, decisions, and action items in the Design Review Record.

4.3 Verification and Validation
4.3.1 Design Verification
– Perform verification activities to confirm that design outputs meet design input requirements.
– Include test results, inspection reports, and analysis data in the DHF.

4.3.2 Design Validation
– Validate the design under actual or simulated use conditions to ensure the device meets user needs and intended uses.
– Document validation protocols, test data, and conclusions in the DHF.

4.4 Managing Risk Documentation
4.4.1 Integration with ISO 14971
– Include risk management documents in the DHF, such as the Risk Management Plan, Hazard Analysis, and Risk Assessment Reports.
– Ensure risk control measures are validated and linked to design outputs.

4.4.2 Post-Market Risk Updates
– Update the DHF with new risk data from post-market surveillance or field performance reviews.

4.5 Change Control in the DHF
4.5.1 Documenting Changes
– Record all design changes in the DHF, including the reason for the change, affected documents, and approvals.
– Use the Design Change Request (DCR) form for initiating and documenting changes.

4.5.2 Verification and Validation of Changes
– Re-verify and re-validate changes as necessary to ensure continued compliance with design inputs and regulatory requirements.
– Update impacted DHF documents with revised versions.

4.6 DHF Review and Approval
4.6.1 Periodic Review
– Conduct periodic reviews of the DHF to ensure completeness and compliance with regulatory updates.
– Document review findings and corrective actions in the DHF Review Log.

4.6.2 Final Approval
– Before product launch, obtain final QA and regulatory approval of the DHF.
– Ensure the DHF is archived in its entirety, with no pending action items.

4.7 Documentation and Record Keeping
4.7.1 Version Control
– Assign a unique version number to each DHF document and maintain a version history.
– Archive superseded versions to prevent unintentional use.

4.7.2 Secure Storage
– Store DHF documents in a secure electronic document management system (EDMS) with controlled access.
– Maintain backups to prevent data loss.

4.7.3 Retention Period
– Retain DHF records for the product’s lifecycle or as required by regulatory authorities, typically five to ten years post-market.

5) Abbreviations

– DHF: Design History File
– QA: Quality Assurance
– DCR: Design Change Request
– EDMS: Electronic Document Management System
– SOP: Standard Operating Procedure

6) Documents

– Design and Development Plan
– Design Input Specification Form
– Design Review Records
– Risk Management Plan
– Design Verification and Validation Reports
– Design Change Request (DCR) Form
– DHF Review Log

7) Reference

– FDA CFR Title 21, Part 820.30: Design Controls
– ISO 13485: Medical devices – Quality management systems
– ISO 14971: Application of Risk Management to Medical Devices

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Design Input Specification Form Template

Input ID	Description	Source	Verification Method	Approval
DI-001	Material must be biocompatible	ISO 10993	Material Testing	QA Manager

Annexure 2: Design Change Request (DCR) Template

Change ID	Description	Reason for Change	Affected Documents	Approval
DCR-001	Update tolerances for component X	Improved manufacturability	Drawing X-001, Spec X-002	Design Lead