Notified bodies have been performing remote audits for months now in response to the COVID pandemic.

https://youtu.be/mne7vcrqkkM You've heard me tell you often enough that the first stage of regulatory grief is

Bargaining may work in politics or at the flea market but it won't help you gain FDA approval for your device. 😕

The second stage of regulatory grief is anger. 🤬 Anger aimed at the regulatory gods for getting in the way of your

It's so easy to remain in an extended state of denial these days. 😒 COVID continues to wreak havoc on your go to market

Y'all know that I am a big fan of appropriate regulation. 🤓 And having only properly validated medical devices and

Heads up, regulatory peeps. The Notified Bodies may flag a product's IFU for 𝙣𝙤𝙩 𝙬𝙖𝙧𝙣𝙞𝙣𝙜 𝙖𝙜𝙖𝙞𝙣𝙨𝙩 𝙩𝙝𝙚 𝙪𝙨𝙚 𝙤𝙛 𝙡𝙖𝙩𝙚𝙭

In The Matrix, Keanu Reeves is offered the choice between a red pill and a blue pill. 💊 The red pill represents an

Just when you thought it might be safe to go back to your normal regulatory process. 😲

Baptism by fire gets a bad rap, and rightly so. It can be a very stressful and ineffective way to learn the ropes of a