Regulatory strategy got you down? Aching head from trying to understand what process controls apply to your device? FDA

You and FDA are going to get pretty cozy before you are granted clearance – the 'marriage certificate' in our little

How long have you been dating your Notified Body – "NB" for short? Is your eye beginning to wander?It should wander if

Why do you care about regulatory change? Keeping pace with change generates cash flow. Your product gets to market

Why? This is why: If I'm going to save you from reading this (what's the word?), um, stuff, I'm going to have to

These are my new friends Ellen Karges and Vrushali Tembe! I met these lovely ladies when I presented "FDA Use of

This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” (See the first

This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the

Manufacturers everywhere waited a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping

If you have not been scared enough by Halloween, read this consent decree announcement made by the FDA on November 1 to