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To meet the FDA’s standards for medical devices, you must complete user interface specifications or requirements. So how do you properly complete the user needs section of user interface [...]

The success of your medical device is contingent upon having a comprehensive project plan to guide its development. To help, access our project plan example. It’s tailored exclusively to medical [...]

A traceability matrix helps you define and track product requirements to reduce risk and carry initial insights through to realized products. Our template and traceability matrix explainer guide [...]

Who you hire to support your medical device’s development may actually be hindering it. Even though you need outside help to bring your product to fruition, not all development partners are [...]

To successfully get a medical device to market, there’s a complex network of reporting, testing, certifications and submissions that need to be completed. One certification in particular often [...]

Even though the risk management process is continuous, you can break it down into steps to make it more manageable for you and your team. Let’s explore the steps that should happen after you’ve [...]