Healthcare & Med Tech Product Development

As a result, this covers the entire product development cycle, from medical device design to clinical trials, and risk management to manufacture.
The FDA, for example, set out five stages for processing medical devices to prepare them for market. These stages form their quality system regulation (QSR), which governs “the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices intended for human use.”