2023 update – Best Practices for Design Controls for Connected Medical Devices
Some of the first of many complexities that medical device startups must manage are design controls. While design controls can seem confusing, arbitrary, or even restrictive, they flow from regulatory agencies’ mandate to ensure public safety. Agencies use design controls to ensure the safety and efficacy of connected medical devices. Medical device startups
A Beginner’s Guide to Design Controls for Connected Medical Devices
What do you need to know about design controls for your connected medical devices? Our beginner’s guide breaks down the key components: