The not-so-practical “practical guide” to ISO 13485:2016 (Part 1)

How do you make the business case for MDR? You need to do a product portfolio rationalization. For some of your

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

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

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

Blame the snake-oil salesmen. It's mostly their fault that we ended up with so much medical device regulation in the

Let's face it - no one likes being told what to do, and device manufacturers are no exception. But FDA approval of your