Yes, the software can be a medical device. The Food and Drug Administration (FDA) has defined medical devices as “instruments, machines, implants, in vitro reagents, and other similar or related articles, including parts or accessories,” which are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” In other words, as long as a software product meets the definition of a medical device, it can be regulated by the FDA.
If you are a medical device manufacturer, you know that you need to validate your software in order to meet FDA requirements. But what does that mean, exactly? And how do you go about it? In this blog post, we will discuss the FDA software validation requirements and provide some tips on how to comply with them.
First, let’s define software validation. Software validation is the process of ensuring that a software system meets all the requirements that have been specified for it. This includes functional requirements (e.g., the software must be able to perform certain tasks), as well as non-functional requirements (e.g., the software must be user-friendly).
In order to validate your medical device software, you will need to follow these steps:
• Plan: Define what needs to be validated and how it will be done.
• Execute: Perform the actual validation tests and document the results.
• Evaluate: Analyze the results of the tests and make sure they meet all the requirements.
If you want to le arn more about software validation, we recommend checking out our blog post on the subject. And if you have any questions, feel free to contact us – we’re always happy to help!