Real talk on risk management in medical device development
Getting a handle on risk management in medical device development is probably the most stressful part of the entire R&D process, but it's ultimately what keeps patients safe and companies out of legal trouble. If you've ever sat through a three-hour meeting arguing over whether a software glitch counts as a "hazardous situation" or a "harm," you know exactly how granular and, frankly, exhausting this can get. But we can't just "move fast and break things" when those "things" are insulin pumps or heart valves. ...