Gregory Montalbano

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...