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