and resource requirements.

4.1.2 Risk-Based Approach
– Prioritize V&V activities based on:
– Criticality of device functions.
– Identified risks and severity of potential failures.
– Regulatory requirements for high-risk components or features.

4.2 Verification Testing
4.2.1 Defining Verification Criteria
– Ensure verification testing confirms that design outputs meet specified design inputs, including:
– Functional performance (e.g., accuracy, reliability).
– Environmental tolerance (e.g., temperature, humidity).
– Safety requirements (e.g., compliance with ISO 14971).

4.2.2 Conducting Verification Tests
– Perform tests using standardized methods, such as:
– Mechanical testing for durability.
– Software verification for embedded systems.
– Electrical safety tests for powered devices.
– Record test results in the Verification Testing Log.

4.2.3 Reviewing Results
– Compare test results against predefined acceptance criteria.
– Document non-conformances and implement corrective actions if necessary.

4.3 Validation Testing
4.3.1 Defining Validation Objectives
– Confirm that the final device meets user needs and intended use through:
– Usability testing.
– Clinical evaluations.
– Simulated use testing in real-world conditions.

4.3.2 Conducting Validation Activities
– Include end-users and clinical experts in validation activities.
– Focus on:
– Human factors engineering and usability.
– Device performance in clinical settings.
– Compatibility with other systems or accessories.

4.3.3 Analyzing Validation Results
– Compile and analyze results to determine whether the device fulfills its intended use.
– Address gaps or failures with iterative design improvements.

4.4 Reviewing and Approving V&V Results
4.4.1 Internal Review
– Review V&V results with cross-functional teams to ensure:
– Completeness and accuracy of test documentation.
– Alignment with regulatory requirements and user expectations.

4.4.2 Approval Process
– Obtain formal approval of V&V results from QA and senior management.
– Record approvals in the V&V Approval Log.

4.5 Managing Changes and Updates
4.5.1 Handling Test Failures
– Investigate root causes of failures identified during V&V testing.
– Update design outputs and re-conduct testing as necessary.
– Document changes in the Change Control Log.

4.5.2 Updating V&V Documentation
– Revise the V&V plan and associated test protocols if new risks or requirements arise.
– Communicate updates to all relevant stakeholders.

4.6 Documentation and Record Keeping
4.6.1 V&V Documentation File
– Maintain a file containing:
– V&V plan and protocols.
– Test results and data analysis.
– Approval records and traceability matrices.
– Non-conformance reports and corrective actions.

4.6.2 Retention Period
– Retain V&V documentation for at least five years or as required by regulatory authorities.

5) Abbreviations

– V&V: Verification and Validation
– QA: Quality Assurance
– ISO: International Organization for Standardization
– SOP: Standard Operating Procedure

6) Documents

– V&V Plan
– Verification Testing Log
– Validation Test Results
– Change Control Log
– V&V Approval Log

7) Reference

– FDA CFR Title 21, Part 820: Design Controls
– ISO 13485: Medical Devices – Quality Management Systems
– ISO 14971: Application of Risk Management to Medical Devices
– IEC 62366: Usability Engineering for Medical Devices
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Verification Testing Log Template

Date	Test ID	Description	Results	Remarks
DD/MM/YYYY	VT-001	Functional Performance Test	Pass	Met all specifications

Annexure 2: V&V Approval Log Template

Date	Approval ID	Description	Approved By	Remarks
DD/MM/YYYY	APP-001	Validation of usability testing	QA Manager	Approved without changes