For well over a decade, the FDA has placed intense focus on how use errors contribute to the majority of adverse medical events. This focus has driven the generation and implementation of...

With its numerous steps and intricacies, the process of receiving FDA approval can easily be seen by those working with medical devices as the proverbial brick wall waiting at the end of the...

Meeting regulatory standards and acquiring FDA approval is the last major hurdle to overcome before a new medical device can enter the market, serve its intended purpose, and benefit its intended...

Medical devices entering the market today have many barriers to overcome before being put into use, and for a good reason. The FDA and other governing bodies, as well as the guidance they set forth,...

All products designed for human use must account for the specifics of its users. Everything from physicality to emotional state can influence the success of a product or its failure. This is...