# Design History File Summary

> Use this template to dHF summary for [device_name] and design control evidence.

## Template Metadata

| Field | Details |
|-------|---------|
| Category | Medical Devices |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |

## Device Overview

Identify device name, model, intended use, classification, markets, and design project scope.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Design Inputs

Summarize user needs, regulatory requirements, standards, safety requirements, and performance requirements.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Design Outputs

List drawings, specifications, software items, labeling, manufacturing instructions, and packaging outputs.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Verification

Summarize verification activities proving design outputs meet design inputs.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Validation

Summarize clinical, usability, simulated-use, or production-equivalent validation evidence.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Design Reviews

Record major review milestones, participants, decisions, and open items.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Traceability

Explain how inputs, risks, outputs, verification, and validation are linked. Use tables and keep claims traceable to controlled records.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]