Medical Device Software Validation

Medical Device Software Validation

        Medical Device Software Validation is the process of confirming that a product, which could be hardware, software, or software as a medical device (SaMD), meets its         intended use. In this context, “intended use” refers to the high-level requirements set forth during the device’s design phase, i.e., the needs of the user.

        This validation process is crucial for all FDA-regulated companies as it helps prove that the software can produce accurate and consistent results. The Food and Drug         Administration (FDA) outlines general validation principles that are applicable to the validation of medical device software.

        Moreover, software validation is becoming increasingly important in medical devices and digital adoption more broadly. Rapid innovation in technology has driven significant         changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions, or directly provide therapy to an         individual.

        It’s important to note that software validation is not just about checking if the software works as expected, but also about ensuring that it meets the needs of the user and         complies with regulatory requirements such as such as ISO13485, ISO14971, IEC 62304, and IEC 82304 .

 

Our team is ready to offer the right advice to ensure that your software complies with all essential regulatory standards.