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