Can You Reduce Device Risk Just By Informing the User?

Over 20 years ago, a doctor phones a medical device company’s technical service group from nearly half a world away, and is in a panic. He’s performing his first implant of the newly available AICD technology, and his patient is sedated, on the table and there is a problem. “I’ve implanted […]

By |July 7th, 2015|Product Engineering, Quality|0 Comments

Risk, FMECA and an Engineer’s Creativity

My wife walked in the door with a big sigh years ago after taking our young son to Toys ‘R Us. She realized he was going to take after his engineer father when, after picking an interesting toy off the shelf, he turned it over to see how it worked instead of just playing […]

By |June 8th, 2015|Product Engineering, Quality, Regulatory Support|0 Comments