So You Want to be a Regulatory Consultant?

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,

I recently caught up with my buddy Randy Horton over at Orthogonal, and we did a deep dive into the evolving landscape

In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO

Clients find lots of creative ways to ruin their FDA submission strategy. Doing their own research is one, and huge

Risk = 𝙎𝙚𝙫𝙚𝙧𝙞𝙩𝙮 of harm x 𝙥𝙧𝙤𝙗𝙖𝙗𝙞𝙡𝙞𝙩𝙮 of occurrence of harm Don't panic! Even if you were traumatized by eighth-grade

Remember what I said about MDR no longer being legislation but interpretation? Here's another example for you: My

The FDA's biocompatibility bouncer will get you every time, no matter how many times you try to sweet-talk your way

  (This is an edited transcript of the video clip, but here's the link to the full presentation) Do you