medical device

Medical Device Product Development Process

Product development, at the highest level, consists of 1) Discovery, 2) Development, and 3) Commercialization. Some companies use a phased-and-gated process to manage their product development projects. Regardless of the process followed, it most likely contains some form of these three main elements. Within each main element, the core product development functions (product management, engineering/R&D, operations, and quality) carry out different activities to make the product successful.

The product development process includes the entire product life cycle, from identifying customer needs to designing a product that addresses those needs, to introducing the product into the marketplace, and finally to addressing end-of-life considerations.

Often we find that companies have instituted design controls as their product development process, rather than integrating design controls within the product development process. While design controls contain elements of engineering practices, they are not a replacement for a product development process.

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