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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 [...]

You're not tearing down to reverse engineer something but rather to spring toward innovation. Tearing it down will give you a great foundation of needed knowledge. Engineers tend to just worry [...]

As you develop a medical device, there will be moments it becomes apparent you need outside assistance. No matter the crossroads you’re facing on your medical device design and development [...]