P2.2 Detailed development of solution

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 [...]

Medical devices are often entirely custom, but what happens when you don't want to get into the business of making a custom display? Or a computer? These electronic devices have to conform to [...]

Developing a medical device first requires defining precisely what that product is supposed to do. Discussion among stakeholders often elicits vastly divergent ideas. The challenge here is for [...]

The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps [...]