1 Purpose

This document describes the Design Verification and Validation activities, taking place during phase 3 and
4 of the product development process according to Design control Procedure (Error: Reference source
not found), for the COMPANY PRODUCT.

2 Scope
This document provides an overview of all of the PRODUCT Design verification and validation activities
including guideline for tests execution and recording, responsibilities and high-level test list. Information
regarding the System description and the Intended use are described in the PRODUCT Description (Error:
Reference source not found) and Use Specifications (Error: Reference source not found & Error:
Reference source not found).

3 Definitions and Abbreviations

4 References and applicable documents

5 Design Verification and Validation Overview

5.1 Design V&V Objective
Design verification testing will be conducted to demonstrate that the design of the system
satisfies all the system requirements, software requirements, risk management concerns and
regulatory requirements. Validation testing will be performed to satisfy the User requirements
and Intended Use. When applicable, the verification and validation protocols will include
description of challenge tests that exceed design requirements.
5.2 Test Groups and Type
The tests described in this plan (refer to PRODUCT Verification and Validation Test Plan section)
are divided logically into groups according to Component being tested (PRODUCT components),
test category and responsible discipline group
(Mechanical/Electrical/Product/Medical/Quality/Clinical). Each group of tests category is
independent of other groups of tests, and the outcomes of one group do not influence the
outcomes of any other group. As such the table in the V&V plan section does not depict the
order of the testing. If within a group the order is significant it will be defined in the individual
protocols.

6 Individual Protocols and Reports

For each test detailed, individual testing protocols and reports will be developed according to Design
Verification and Validation Instruction (Error: Reference source not found) or Software Development Life
Cycle Process Procedure (Error: Reference source not found) and when applicable Process Validation
 Instruction (Error: Reference source not found). The protocols will be released as controlled documents
before the testing begins. The reports will also be released after tests are completed, together with all
test reports (including external laboratory reports) and collected data.

The test protocols will describe and specify the details of each of the mechanical, electrical, software and
system tests including product/component to be tested, equipment and materials, detailed testing
protocol, sample size and acceptance criteria. In the instance that tests are to be conducted at external
test laboratories, the protocols will indicate the specific external laboratory.

The test reports shall document the outcomes of all the tests conducted under the respective protocol.
The report shall include a summary of test results along with justification for any deviations in test steps
specified in the respective protocol. The test report shall reference the protocol as the foundation for all
tests conducted and documented in the report. In the instance that tests are to be conducted at external
test laboratories, the external laboratory reports will be attached to summary reports as supporting
documents and released.

7 Execution of Verification and Validation Tests

7.1 Responsibility for Tests Execution
The team which was responsible for the development of that component, writing the protocol,
overseeing the test execution and writing the report is specified in the table in the PRODUCT
Verification and Validation Test Plan section of this document. The individuals performing the
tests will comprise of trained and qualified representatives from R&D, Product, and Clinical
department, or, where applicable, by external laboratories which are qualified as approved
suppliers under the COMPANY quality system. The details of the individuals performing the tests
will be specified in the individual reports.
7.2 Test Methods and Equipment
The test methods adopted for V&V testing are mostly standard test methods using the
appropriate equipment and based on test protocols designated by the appropriate standard. In
general, standard laboratory equipment will be used for measuring quantities such as
temperatures, pressures, and voltages. It will be ensured that all such pieces of standard
laboratory equipment are calibrated in accordance with COMPANY standard procedure for
equipment calibration (Error: Reference source not found).
7.3 Data Collection
Data acquired during execution of the tests shall be gathered and appended to the test report.
When applicable, dedicated tables/sections in the protocol will be used as data sheet. In
addition to the test data collected, test records shall include the name of the tester, the date the
test was performed, and a description / ID number of any general- or special-purpose equipment
used in the test. If outcomes do not match expectations, the tester can use a “comments”
section provided for each group of tests to record deviations from expectations. All data sheets
containing the test data Test Facilities
V&V testing will be conducted in the R&D laboratory at COMPANY as well as in external, ISO
17025 and/or GLP (or equivalent) accredited, testing laboratories. Usability may be conducted in
an office at COMPANY, anatomy laboratory, pre-clinical institute or at clinical sites as
appropriate, according to the test being performed.
 7.4 Archiving of Test Articles
Individual protocols should specify If test article or a representative sample from the same LOT
should be archived. Archive location and duration shall be specified in the individual test report.

8 Sample Sizes
Sample sizes for V&V testing will depend on the test being conducted and in accordance with Error:
Reference source not found (Statistical Techniques). In many instances where inherent variability
between samples is known to be negligible, a sample size of one is sufficient (for example SW and specific
Hardware validations). Larger sample sizes may be used when sample-to-sample variability is known to
be non-negligible. The detailed testing protocols will specify the number of test samples for each test
including sample size rationale where applicable, along with the statistical techniques used and
associated pass/fail criteria.

9 Traceability
The individual V&V reports generated by the testing will be traced back to requirements in the System
Requirements, Software Requirements, and Risk Analysis documents. The tracing will demonstrate that
all the design requirements have been met. Traceability will be documented in the form of one or more
traceability matrices.

10 Dealing with Test Failures

Although the majority of formal V&V testing will be preceded by informal R&D testing to gain confidence
that the design meets the input requirements, it is possible that test failures will be encountered in the
entire suite of V&V tests. If a test failure occurs, it will be analyzed by members of the project team. The
team may take one of the following g decisions:
 Consider the failure to be an insignificant risk and, with documented justification, waive the
requirement;
 Consider increasing the sample size for the test;
 Consider the requirement to be overly stringent and, with documented justification, relax it such that
the test is deemed to have been passed;
 Require the design team to revise the design, consider the ripple effects from the design change, and
repeat all tests affected by the design change;
 Repeat the test. Retesting, with documented justification, shall be allowed in circumstances such as:
o The test was inappropriate for the tested device
o The device under test failed due to unrelated causes

The project team’s deliberations will be treated as design reviews and be documented accordingly (Error:
Reference source not found).

11 Master V&V Report

Master V&V Report will summarize all individual test reports. To provide the reader with an overview of
all V&V tests, the Master V&V Report will include a table that presents a brief description of the tests, the
objectives of the tests, a broad description of the acceptance criteria and results associated with these
tests. A review of this table may be helpful before diving into the details of individual protocols and
reports.
12 Responsibilities
The VP R&D (as applicable) is responsible for determining the extent of verification and validation
required and the degree of assurance as a result of the Risk Management and/or other techniques.

The VP R&D has overall responsibility for the performance and documentation of the verification and
validation activities.
13 PRODUCT Verification and Validation Plan

The table below summarizes the individual design verification and validation activities per component, test or analysis category and discipline.

Confidenc
Test/ Standard(s) Responsible
Component Category Test ID Description Location FMEA e/
Analysis /Spec Team
Reliability

Pre-Clinical
Study

Clinical
Study