QMSR and ISO 13485: Deciphering the Differences

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

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

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

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