# Medical Device Design Input Traceability Matrix Worksheet

> Source: https://netray.co/tools/medical-device-design-input-traceability-matrix-worksheet
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

Editable traceability matrix linking each design input to its design output, verification, validation and risk control.

## Category

engineering-plm

## Industry

Medical Devices

## Audience

- Design engineer
- Quality engineer
- Regulatory affairs

## Tool

**Kind:** worksheet

**Mode:** editable

**Columns:**

#### Input ID

**Key:** id

**Type:** text

#### Design input requirement

**Key:** requirement

**Type:** text

#### Source

**Key:** source

**Type:** select

**Options:**

- User need
- Regulatory
- Standard
- Risk control
- Interface

#### Design output

**Key:** output

**Type:** text

#### Verification method

**Key:** verif

**Type:** select

**Options:**

- Test
- Inspection
- Analysis
- Demonstration

#### Verification record

**Key:** ref

**Type:** text

#### Status

**Key:** status

**Type:** select

**Options:**

- Open
- In test
- Verified
- Failed

#### Linked risk ID

**Key:** risk

**Type:** text

**Rows:**

**Id:** DI-001

**Requirement:** Flow rate 100 mL/h +/- 10% at 1 m head

**Source:** User need

**Output:** Drawing IS-200-01 orifice 0.20 mm

**Verif:** Test

**Ref:** DVP-0042

**Status:** Verified

**Risk:** R-012

**Id:** DI-002

**Requirement:** Tubing joint tensile strength min 15 N

**Source:** Standard

**Output:** Bond spec BS-014

**Verif:** Test

**Ref:** DVP-0043

**Status:** In test

**Risk:** R-015

**Id:** DI-003

**Requirement:** Device sterile, SAL 10^-6

**Source:** Regulatory

**Output:** Sterilization spec SS-002

**Verif:** Analysis

**Ref:** VAL-EO-001

**Status:** Open

**Risk:** R-020

**Id:** DI-004

**Requirement:** Label includes UDI barcode and expiry date

**Source:** Regulatory

**Output:** Label artwork LBL-200

**Verif:** Inspection

**Ref:** INSP-0019

**Status:** Verified

**Risk:** R-031

**Id:** DI-005

**Requirement:** Luer connector fits ISO 80369-7

**Source:** Standard

**Output:** Drawing IS-200-04

**Verif:** Test

**Ref:** DVP-0045

**Status:** Open

**Risk:** R-008

**Totals:**

#### Total design inputs

**Key:** id

**Agg:** count

**Notes:** Use one row per design input. Every row should have a design output, a verification method and a record reference before design transfer. Keep a copy in the design history file.

## Content

**Intro:** A design traceability matrix shows that every design input is realised in a design output and checked by a verification. It is the quickest way for an auditor, or your own design review, to see gaps.

**Sections:**

#### How to use the matrix

**Body:** List each design input as a row with a unique ID and its source. Add the design output that satisfies it, choose test, inspection, analysis or demonstration for verification, and record the protocol or report number. Link a risk ID if the input is a risk control, so risk management and design controls point at each other. Update the status as testing proceeds and export to Excel for design reviews.

#### Why it matters

**Body:** ISO 13485 7.3 and 21 CFR 820.30 require design inputs to be documented, outputs to trace to inputs, and verification to be recorded. ISO 14971 expects risk control measures to be verified for implementation and effectiveness. For software, IEC 62304 requires traceability between requirements, tests and risks. A single matrix serves all three.

**Bullets:**

- Gaps show up as blank cells
- Supports design review evidence
- Links risk controls to verification
- Feeds the design history file index

#### Common mistakes

**Body:** Teams write inputs that cannot be tested, such as 'device shall be easy to use', and then have no acceptance criteria. Others list outputs without versions, so the trace breaks after a change. Make each requirement measurable, reference released document revisions, and re-run the matrix review after every design change.

**Cta:** If your requirements and tests sit in PLM, ERP and spreadsheets, Netray can help build a single traced view. Ask for a short review.

**Faq:**

#### Does every input need a verification?

**Answer:** Yes. Each design input should be verified by test, inspection, analysis or demonstration, with a record. Some inputs are covered by validation instead, but that should be stated explicitly.

#### Where does the matrix live in the DHF?

**Answer:** It is usually a controlled document listed in the design history file index and revised under change control as the design evolves.

#### Can I use this for software requirements?

**Answer:** Yes. Add columns for software item IDs and unit test references if you need IEC 62304 level traceability.

#### How often should I review it?

**Answer:** At every design review and after every design change, and before design transfer to confirm no row is open.

## Search terms

design traceability matrix excel, requirements traceability matrix medical device, design input output verification matrix, design history file traceability, ISO 13485 traceability matrix template, IEC 62304 requirements traceability

---
Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json