Our last agile development post focused on the big picture: when, how, and why to depart from the classic waterfall development model in favor of lean and agile practices. But what does that look...
Part 820 is wide-reaching. In order for a medical device company to fully understand what compliance with Part 820 means, further elaboration is required. Two of the most important areas this applies...
FDA approval can be achieved in two ways: The 510(k) process, in which the manufacturer must provide evidence that the device they intend to market is “substantially equivalent” to a device already...
Federal standards governing the safety and efficacy of medical products have been overseen in the United States by the FDA since the original 1906 Food and Drugs Act. The approach to medical product...
At the outset of a project, natural momentum will tend to move engineering and development teams very quickly from “What” (problem and requirements) to “How” (methods and solution details). This...
