Blog | Regulatory + Quality Assurance | Michelle Lott

We led an effort to overturn an FDA rule to down-classify 91 devices to Class 1 or 2 and make them 510(k) exempt....

Learn More

As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions typica...

Learn More

Why do we need a document control process? Oh, if only I had a nickel for every time I’ve been...

Learn More

How do you determine the correct FDA submission for combination products? What IS a combination product? A combination p...

Learn More

Very few days go by without someone asking me to explain the differences between FDA submission types. This most often...

Learn More

If you think that getting a medical device onto market is a long and tedious process, be glad you don’t...

Learn More

News, Blogs, and Other Tidbits