PLANREFERENCE OUTLINE

Design and Development Plan and Traceability Record

Design and development plan and traceability record covering every stage the QMSR now requires through ISO 13485 clause 7.3: applicability under 21 CFR 820.10(c), stages and responsibilities, the risk management link, inputs written to be testable, outputs, reviews, verification, validation on representative product, transfer, change control, a needs-to-validation trace matrix, and the design and development file index.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 820ISO 13485:2016ISO 14971:2019
DOCUMENT TYPE
Plan
LAST UPDATED
October 2026
PURPOSE

The plan and running record for a device's design and development, built so that the design and development file exists from the first stage rather than being assembled before a submission. Design history is the record founders most often lack and can least rebuild; this template makes each stage leave the evidence ISO 13485 clause 7.3 asks for, and traces it from user need to validation.

What's Inside

✓Applicability under 21 CFR 820.10(c), device identification and the design and development file reference
✓Stages, the review closing each stage, responsibilities, external interfaces and the traceability method
✓The link to the documented risk management process that clause 7.1 requires
✓Design inputs written to be testable, and design outputs with acceptance criteria and safety-essential characteristics
✓Design reviews, verification and validation tables with methods, acceptance criteria and results
✓Design transfer and design change control, including the regulatory impact of each change
✓A traceability matrix from user need through risk control, output, verification and validation, and a design and development file index

How to Use It

1Confirm applicability first: § 820.10(c) applies clause 7.3 to class II and III devices and to listed class I devices, including every device automated with computer software
2Start the plan at the end of feasibility; FDA states design and development is required before a clinical evaluation such as an IDE and before a marketing submission
3Write each input so a test can fail it, and resolve conflicts between inputs at the input review
4Keep the traceability matrix current as you go and read it in both directions — untested inputs and untraced outputs are both findings
5Validate on product representative of production, and record why it is representative
6After a submission or Pre-Sub has described the design, assess every change for regulatory impact and record the assessment even when the answer is no
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Applicability and Device Identification
2Stages, Reviews and Responsibilities
› Resources and interfaces
3Risk Management Linkage
4Design Inputs
5Design Outputs
6Design Reviews
7Design Verification
8Design Validation
9Design Transfer
10Design Changes
11Traceability Matrix
12Design and Development File Index
AAppendix A — Approval
REGULATORY CONTEXT

Under the QMSR, design and development requirements come from ISO 13485:2016 clause 7.3 (7.3.1 to 7.3.10), applied by 21 CFR 820.10(c) to class II and class III devices and to the listed class I devices. Clause 7.1 requires documented risk management processes in product realization; ISO 14971:2019 is the international standard on applying risk management to medical devices, but Part 820 does not incorporate it, so applying it is the manufacturer's choice to record. The QMSR final rule (89 FR 7496) retired the term design history file: the design and development file of clause 7.3.10 contains or references the records showing conformity, including the plan and the design procedures. Classification and pathway are your determinations; this plan records them and does not make them.

MAPPED STANDARDS
21 CFR Part 820ISO 13485:2016ISO 14971:2019
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