Medical Device Regulation and Ye Olde Snake-Oil Salesman

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

Clear some space on your regulatory bookshelf! You're going to need room for your copy of the UK's newly-adopted

Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but