In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO

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

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

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

You KNOW  your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to

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

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

Let's start the day with some much-needed good news from the EC. They've released a new guidance aimed at making it