1 Purpose

The purpose of this document is to provide detailed instructions on how to perform the PRODUCT
Dimensional verification test as part of the Design Verification and Validation process.

2 Scope
This document applies to the PRODUCT. The document scope includes description, responsibilities,
article description and sample size, equipment list, method, procedure, acceptance criteria,
protocol deviations, report, and records.

3 Definitions & Abbreviations

4 References and Applicable Documents

5 Description
5.1 Reason for Test
The Dimensional Verification test is performed to verify that the PRODUCT is produced and
assembled so that the final product complies with the dimensional requirements detailed in
the PRODUCT Requirements...

5.2 General Description

Measurements of the PRODUCT will be taken by a trained COMPANY employee according
to the method section of this document to verify they are aligned with the requirements of
the PRODUCT Requirements.

5.3 Testing Guidelines

This test is performed according to the guidelines detailed in the PRODUCT Master
Verification and Validation Plan, and Design Verification, and Validation Instructions.

6 Responsibilities
1. Tests will be conducted in COMPANY by COMPANY trained and qualified employees.
2. An R&D engineer will be appointed as test director. It is the test director's responsibility
to approve this the protocol, appoint and train testing representatives, choose and
authorize an external lab, coordinate the test with the lab, oversee the test
exPRODUCTtion, approve the final report, collect samples and data sheets, and transfer
them to the QA team for archiving.
3. The QA team is responsible for assuring all documentation is meeting guidelines
provided in Design Verification and Validation instructions and Master Verification and
Validation Plan
 7 Article Description and Sample Size
7.1 Article Description Table
Item Articles Tested HW/FW/BOM version Quantity
1
2

7.2 Article building process

The actual manufacturing system will be used for the article building process, as defined by
the DMR index

7.3 Sample Size and Rationale

The testing in this protocol will be based on a risk-based approach. In accordance with V&V -
Statistical Rational, Confidence/Reliability are determined by the Severity/Frequency of the
risk the test is intended to mitigate.
Related risks in the DFMEA (Error: Reference source not found) are: DEMFC06, DEMFC07
and the related risk in UFMEA (Error: Reference source not found) is: UET3.
The table below shows the highest Frequency/Severity combination for each test/risk and
the corresponding Confidence/Reliability value. The criteria for these tests are non-numeric
values (Attribute) and the sample size number is according to Error: Reference source not
found, assuming no failures.

Freq./
Severity
FMEA Risk ID (Error:
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Sample size justification
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8 Equipment List/Simulation Tools
Model / specific
Item Equipment Required Accuracy Level Notes
requirements

9 Method
9.1 Setup Description

9.2 Testing General Instructions

1. Only calibrated tools and equipment will be used in the testing.
2. Tests will be conducted at COMPANY by COMPANY trained and qualified employees.

10 Procedure
Step Description Notes
1.
1.1.
2.
2.1.
2.2.
2.3.
2.4.
3.
3.1.
3.2.
3.3.
3.4.
3.5.
4.
4.1.
4.2.
11 Acceptance Criteria
Acceptance criteria are chosen to verify that the PRODUCT is designed so that the final product
complies with the mechanical requirements detailed in the PRODUCT Requirements

11.1 Requirement and Acceptance Criteria Table

Requirement Acceptance Criteria Notes

EMEC-02: The PRODUCT shall be low weight (≤ 250 grams).
1

EMEC-02: The PRODUCT shall be The PRODUCT shall weigh equal to or less
1.1 Test 1
low weight. than 250[gr]
EUSB-02 - The PRODUCT shall be suitable for applying treatment to patients
with a wide range of leg circumferences at the implantation area
2 (circumference range 20-30cm).
EUSB-03- The PRODUCT shall be suitable for applying treatment to patients
with a wide range of leg aspect ratios (.65-0.90 at the implantation area).
The Leg band shall be able to be mounted
maximum circumference and
2.1 on a 30[cm] circumference cylinder with a Test 2
aspect ratio.
0.9[aspect ratio].
The Leg band shall be able to be mounted
minimum circumference and
2.2 on a 20[cm] circumference cylinder with a Test 2
aspect ratio.
0.65[aspect ratio].
3 ELEG-03: Leg band thickness in the active area shall be minimal (≤3mm)
The Leg Band internal Lycra strap
ELEG-03: Leg band thickness in the
3.1 thickness shall be equal to or less than Test 3
active area shall be minimal.
3[mm].

If a test failure occurs, it will be dealt with in accordance with the guidance provided in the
PRODUCT Master Validation and Verification plan
12 Protocol Deviations
Any protocol deviations will be documented in the test data sheets and later reported in the final
test report along with an appropriate justification. Deviations should be reported to and
authorized by the test director, the moment they are realized. If necessary, the test director will
consult with other relevant positions before approving the deviation.

13 Report
Upon completion of the tests described in this protocol, a full report will be written in accordance
with the guidance provided in the PRODUCT Master Validation and Verification plan and Design
Verification and Validation Instructions.

14 Records
14.1 Test report and protocol
This Protocol should be released in the central computer system before tests are
conducted. Later, final report will be also released in the central computer system, together
with all collected data (Appendix A).
 Appendix A – Data Collection Sheets

Name and position of the test director:

Name and position of the tester:

Tester training date: Trainer name and position: Trainer signature:

Test date: Test Location:

Test Articles

Item Articles Tested S/N HW/FW/BOM version Quantity

1
2
3
4
5
6
7
8

Equipment list

Item Equipment S/N HW/FW/BOM Notes

version/calibration
date
1
2
3
4
5
6
COMPANY Post Results
PRODUCT S/N Weight [gr] Pass/Fail Comments

Leg Band # Thickness[mm] Pass/Fail Comments

Leg Band # Small leg mockup Large leg Comments

compatibility mockup
compatibility
Pass/Fail
Pass/Fail

Protocol Deviations:

Test stage Deviation Justification