The Five Steps to Market: FDA Product Code and Testing Plans

Today we're talking about the third step in the five steps to market process - determining the right class and pathway

Can you name the five steps to market required to move your product from concept to launch? Obviously, we're talking

This conversation is part of Arazy Group Consultants' Regulatory Rockstar Movement, which I was invited to participate

Imagine, if you will, an established medical device player and their newly-acquired subsidiary trying to flex their

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