Product Management in a Regulated FDA Environment Managing product development in a regulated environment, such as one governed by the FDA, presents unique challenges that require rigorous documentation, adherence to regulatory standards, and alignment between design...
The project specs called for an Arduino-based toy platform with an off-the-shelf A4988 stepper motor driver and the ability to drive a WS2812B addressable LED strip. Arduino Nano and their clones run about $2 USD and the A4988 stepper driver runs around $1.50. The toy...
Scott Whitaker sent a letter to the HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S. leadership in medtech are on the line.
