Design and Development – Verification and Validation of ISO 13485
Design and development verification and validation are included in every part of producing a medical device. Verification is the act of determining whether a product or service can meet a specific requirement. Validation is the act of confirming a product or service meets the need for which it was created. Device’s verification and validation are critical to effective manufacturing and compliance with ISO 13485. Medical device company has to ensure the proper records are kept.
The ISO 13485 standard requires you to perform verification activities on the design and development processes and outputs. When the design and development activities are finished, the verification should be performed according to plan:
- The design and development processes were reviewed according to plan
- All necessary inputs were delivered in the right form
- All the required outputs were accepted
- All development tasks were performed and accomplished
The main objective of verification is to confirm if the outputs meet the input requirements. With the verification, the meddev company assures the design and the development activities were performed as expected and that the outputs are appropriate and could be forwarded for later development stages. The verification should be performed through the development processes. The verification activities must confirm that the outputs were accepted and suitable. The medical device company is required to plan verification activities, such as analyses, reviews of outputs, comparisons, simulations, tests, reviews of examples, verifications of other established products. The results of the verification activities are must be documented. The results have to include the outcome of the verification activities and nonconformities – if the outputs weren’t appropriate. With such cases, the company should submit the outputs to the process of control of nonconforming products as required in the clause Control of Nonconforming Product.
Every medical device company is obligated by the standard to validate the design and development to ensure the outputs and the product meet the specifications of performance, safety, functionality, and intended use. The validation is a test planned to confirm, with objective evidence, that the medical device satisfies its users’ requirements. The validation delivers evidence that the medical device and/or a realization process conform to its specifications before the release for realization.
The main goal of the validation is to produce objective evidence representing the medical device is designed and developed by specific requirements, and that it will meet these requirements consistently. The requirements are predefined – intended use requirements, functionality, performance, and safety specifications. The validation activities will regard the following issues:
- Medical device specifications
- Medical device characteristics for validation
- Parameters for validation
- Tools and equipment used for the design and development
- Methods for validation
- Objectives for validation
- Criteria for decisions
- Definition of validation activities
- Required tools and equipment for validation activities
- Required inputs
- Required human resource qualifications
Planning the validation activities shall be done on three levels of the design and development process:
- Validation of elements used for the design and development
- Validation of the compatibility of design and development activities
- Validation of the outputs
With the gathering of data, designated tests, criteria definition, an evaluation method, and the decision, validation levels will be introduced to the process.
The medical device company should ensure that related technical aspects and resources are designed and implemented to achieve the specifications before the design and development activities started, like functionality, intended use, safety, etc. Technical resources are the technical measures that perform processes and generate products or outputs. The following should be verified:
- Design and development equipment and tools
- Development and design environment
- Human resources and
If some of the accessories for development are purchased, the manufacturer is responsible for its testing and validation of functionality.
The company should ensure that design and development outputs and results fulfill the predefined specifications and requirements during design and development activities. Documented results of the validation are meant to be used to demonstrate the effectiveness of risk controls and capture as part of product risk assessment.
Both verification and validation should be documented after their activities are done. As it is required from the company by ISO standard for each requirement, therefore, this isn’t an exception.