The MDR is complex, we all know that. But imagine trying to translate these very complex and multi-layered regulations into a language NOT your own.
In this video clip, Greg and I discuss what can happen to the interpretation of a given regulation when the translation from English into another language is not a word-for-word equivalent.
How to Kill a Product Development Budget in One Easy Step
Y’all know that I am a big fan of appropriate regulation. 🤓 And having only properly validated medical devices and
Learn More
Magic, Madness, MDR and Miniature Dollhouses
MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so. A few weeks ago, my
Learn More
There’s No Bargaining with the FDA
Bargaining with the FDA – or trying to – is the third stage of regulatory grief, but adopting that as
Learn More
Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
