Design Controls and Risk Controls

I’ve said it time and time again - the FDA pre-submission is a valuable tool for companies seeking FDA approval for

Imagine this: you’ve just completed biocompatibility testing for your device, and the data looks great. You assemble the

QMSR and ISO 13485 - talk about a tale of two regulations. QMSR and QSR do sound practically the same, but that one

Congratulations - after years of pouring your heart, soul and ingenuity into the project, you've developed a brilliant

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

As you must know by now, the FDA made eSTAR 5.0 mandatory for 510(k) submissions in October 2023. It's also available

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

Aren't design controls and risk controls essentially the same thing? Uh, no. They are similar, but in the end,