Regulatory Support

The New MEDDEV CER Guidance You're gonna need a bigger boat

The new revision of the EC guidance on Clinical Evaluations (i.e, CERs), was issued in June of this year.  MEDDEV 2.7.1 Rev 3 is now Rev 4.  The industry has provided many ways to learn about the new document via white papers, webinars and conferences (thanks!).  The education has been great, but what’s it like […]

By |November 10th, 2016|Regulatory Support|0 Comments

Product Testing – It Can Really Hurt

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 […]

By |June 28th, 2016|Product Engineering, Regulatory Support|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