Overview Of The Medical Software Development Process


FDA Application Process Overview

To market a medical device in the US, manufacturers need to get FDA approval or clearance for their device. Most medical devices require a premarket notification from the FDA or more commonly known as the 510(K) process. After a device’s design is finalized and all testing is complete, then the device is ready to be […]

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Overview of the Medical Software Development Process

Medical software manufacturers likely find themselves developing and changing their software much more rapidly than their medical hardware counterparts. For software development, there is typically less prototype development and fewer manufacturing or supplier constraints. Still, there are more frequent future revisions to enhance features, maintain compatibility, or remove software bugs. More simply, traditional medical devices […]

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