Working with a Contract Manufacturer? You Still Need a QMS

MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so. A few weeks ago, my

The recent reclassification of blood lancets by the FDA may or may not have caught you by surprise. To bring you up

If you'll indulge a little humblebragging, this is something for my career scrapbook. leanRAQA led a successful

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

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

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

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

If you think that getting a medical device onto market is a long and tedious process, be glad you don't have to deal

Customers ask me all the time - "Michelle, I keep hearing this term - supplier criticality. What does that even

How do you go about choosing the right predicate device? Say you've developed a new tree-borne fruit and you need to