# Design & Development Record (Medical Device)

> ISO 13485:2016 cl.7.3 – the design controls chain: inputs → outputs
> → review → verification → validation → transfer → changes. Also
> feeds the Design History File (DHF) required by FDA 21 CFR 820.30.

| Field | Value |
|-------|-------|
| Device / project | name |
| Document ID | DHF-NNN |
| Risk file | ISO 14971 file ref |
| Stage gate | current phase |

## 1. Design inputs (7.3.3)

| ID | Requirement | Source | Acceptance criterion |
|----|-------------|--------|----------------------|
| DI-01 | User need | intended use | measurable criterion |
| DI-02 | Regulatory requirement | standard/reg | clause |
| DI-03 | Safety requirement | risk file | risk control |

## 2. Design outputs (7.3.4)

- Specifications, drawings, manufacturing instructions, labeling
- Each output traced to input – traceability matrix required

| Input | Output doc | Verified by |
|-------|------------|-------------|
| DI-01 | SPEC-NNN | test method |

## 3. Design reviews (7.3.5)

| Review | Date | Attendees | Inputs covered | Issues | Decision |
|--------|------|-----------|----------------|--------|----------|
| DR-1 | | | | | proceed/hold |

## 4. Verification (7.3.6) – did we build it right?

| Output | Test/method | Acceptance | Result | Pass? |
|--------|-------------|------------|--------|-------|
| SPEC | protocol ref | criterion | | |

## 5. Validation (7.3.7) – did we build the right thing?

- Clinical evaluation / usability / performance in intended use

| Validation | Method | Sample | Result |
|------------|--------|--------|--------|

## 6. Design transfer (7.3.8)

- Outputs transferred to production: procedures, specs, training
- Production verification records

## 7. Design changes (7.3.9)

| Change | Rationale | Re-verification/validation needed | Approved |
|--------|-----------|-----------------------------------|----------|
| | | | |

## Linkages

- Risk management file (ISO 14971) updated with each design change
- CAPA for any verification/validation failure