Medical Device Software Verification Validation and Compliance

The ISO 9001 standard does not specifically require software validation, but it is a requirement of the ISO 9001 standard that organizations demonstrate they have a process in placee to ensure that their software meets their requirements and functions as intended.

At Wi4 Corporation, we believe that the most effective way to do this is through software validation. We have extensive experience in performing software validation and have developed a comprehensive and customizable software validation methodology that ensures our clients’ software meets their requirements and functions as intended.

A medical device verification and validation program is a comprehensive process that is designed to ensure that a medical device functions as intended and meets all safety and regulatory requirements. The verification and validation process typically includes the following steps:

1. Define the product requirements
2. Design the product to meet the requirements
3. Test the product design against the requirements (verification)
4. Manufacture the product and test it against the requirements (validation)
5. Release the product for use in humans

Medical device design validation is the process of verifying that a medical device meets its intended purpose and function and This process ensures that the device is safe and effective for use in humans.
At Wi4 Corporation, we have a team of experienced professionals who can help you with all aspects of medical device validation, from concept to finished product and We can provide support at every stage of the development process, ensuring that your device meets all regulatory requirements. Contact us today to learn more about our services.

Validation is the process of demonstrating that a medical device or system meets all the requirements specified in the applicable regulations, standards, and specifications.

Achieving validation requires a comprehensive approach that incorporates design controls, risk management, manufacturing controls, and testing and the objective of validation is to ensure that devices are safe and effective when used as intended so Validation is an important step in bringing a medical device to market. It helps to ensure patient safety and provides assurance that the device will perform as intended under real-world conditions.