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Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design [...]

Today’s development standards are different, even for medical devices. Products evolve faster because of improved technology as well as new, more readily available use and safety information. [...]

Geometric dimensioning and tolerancing (GD&T) is intimidating even for trained engineers to pick up. GD&T has a set of vocabulary that is initially impenetrable and throws out a lot of [...]

No matter how precise the manufacturing process, there will inevitably be some degree of variation in the components that make up your medical product. All the parts that comprise the finished [...]

From toys and automotive parts to cell phones and mechanical components, injection molded parts can be found in many of the objects we interact with each day. In fact, it would be difficult to [...]

If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration.