P2.3 Qualify design and specs

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 [...]

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 [...]

Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably [...]

Patient safety and reducing hospital stays is the priority for healthcare institutions and one of the focus areas is preventing patients from getting HAIs (Healthcare-associated infections) [...]

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 thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]