Five years ago I wrote about the new MEDDEV 2.7/1 Rev. 4 guidance document for preparing CERs. When that guidance was issued, Notified Bodies widely communicated that while it referred to the MDD, it was written with the upcoming MDR rules in mind. The new MEDDEV guidance served as fair warning for what to expect […]
Imagine a pioneering surgeon inventor and entrepreneur dedicated to proving that his latest medical device is safe by implanting it within the muscle of his own rib cage… by himself. Then, months later, removing it… again, by himself. The surgeon told me that it was a lot more difficult taking the device out than it […]
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 with […]
