ID: Aliquam vitae sapien
The purpose of this document is to outline the verification and validation (V&V) plan for the Suspendisse potenti medical device system, including both hardware and software components. This document ensures that the system meets its design specifications and regulatory requirements.
This V&V plan applies to the entire medical device system, covering hardware, software, and any integrated components.
Verification ensures that the design and development outputs have met the design and development input requirements. Different verification activities planned for the product are outlined below. Subsystem requirements which serve as design inputs can be found in Annex A.
Verification testing methods and approaches are chosen based on applicable standards or, when standardized testing is not required, on the best perceived testing approach. Sample sizes will be defined according to SOP Statistical Methods.
The objective of performance verification testing is to ensure that the performance characteristics of the device as defined in the design inputs
Performance testing will be conducted according to the Performance Verification Protocol. Testing will be performed to ensure that the product’s essential performance as identified through design inputs can be achieved through the design outputs.
The objective of shelf-life verification is to determine the medical device's shelf life, verify that the device maintains its intended functionality, performance, and safety throughout its labeled shelf life, and assess device integrity under real-time and accelerated aging conditions, as needed.
Shelf-life testing applies to all medical devices requiring shelf-life verification as part of regulatory compliance under ISO 11607-1, ISO 13485, and IEC 60601 standards.
Shelf-life testing will be performed according to the Shelf-life Verification Protocol, which will define the methods, acceptance criteria, and statistical techniques with rationale for sample size, as needed.
The objective of packaging testing is to confirm the integrity and performance of the packaging system for Suspendisse potenti. Testing shall be performed on all primary testing and secondary packaging, as applicable.
Test methods will vary based on the type of packaging required for the product. Annex C provides an overview of all packaging tests considered for testing.
Packaging testing will be performed according to the Packaging Verification Protocol, which will define the methods, acceptance criteria, and statistical techniques with rationale for sample size, as needed.
Shipping testing will be performed to verify that the medical device packaging system can maintain the safety, integrity, and functionality of the product during shipping and handling under simulated and actual conditions.
This applies to medical device packaging intended for distribution via standard commercial shipping methods (e.g., UPS, FedEx, freight). Testing can include simulated drop tests and environmental conditioning, as well as validation under actual shipping conditions.
Annex B describes the types of shipping tests that may be performed.
Shipping testing will be performed according to the Shipping Verification Protocol, which will define the methods, acceptance criteria, and statistical techniques with rationale for sample size, as needed.
This device does not contain electrical components.
Biological testing according to the ISO 10993-1 standard will be performed according to the Biological Evaluation Plan, which will define the methods, acceptance criteria, and statistical techniques with rationale for sample size, as needed.
This product does not contain software.
This device does not have firmware.
Validation activities are performed in order to confirm that the resulting product is capable of meeting the requirements for the specified application or intended use. The validation activities shall be performed on representative devices or equivalents. If an equivalent is used instead of the representative device, a justification should be provided.
User acceptance testing and usability evaluations will be conducted according to SOP Usability Engineering and will be conducted according to the Usability Evaluation Plan and Usability Evaluation Protocol.
Performance validation will be performed according to the Validation Protocol.
Clinical validation will be performed according to the Clinical Evaluation Plan and the results of clinical evaluation will be analyzed and summarized within the Clinical Evaluation Report.
A clinical investigation can be an additional source of clinical validation and shall be performed according to SOP Clinical Investigations, if required.
The following criteria should be met in order to perform verification testing:
System requirements and subsystem requirements are created and approved
Verification test plan and subsequent verification protocols are created and approved
Test methods have been validated and are appropriate for the testing required
The product is available for testing
The following criteria should be met in order for verification testing to be considered complete
All verification tests outlined in the verification protocols have been successfully executed
All requirements specified in the scope of this testing effort have been met, as evidenced by tests in a passed state.
Any deviations from the protocol, test failures, or test observations must be recorded and justified.
All issues or anomalies identified during the execution of the test plan that are related to the requirements in scope must be resolved or documented in the List of Known Anomalies.
The following criteria should be met in order to perform validation testing:
Verification testing has been completed
A representative device is available for testing or, if not, a justification for why none is provided is approved
The following criteria should be met in order to for validation testing to be considered complete:
The clinical evaluation plan and report must be completed
Usability evaluation report must be completed, if needed
Any pre-market clinical investigations must be completed, if required
All requirements specified in the scope of this validation testing effort have been met, as evidenced by tests in a passed state.
Vestibulum euismod magna in sapien cursus, vel commodo erat dictum.
Praesent gravida, sapien et dictum sagittis, augue augue dictum velit, nec porta enim erat eu orci.
Nulla facilisi)Morbi ac urna)Curabitur rhoncus)