Are You Making the Most of Your FDA Pre-Submission?

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

Note: QMSR became mandatory in February 2026, three years after this blog was written. Please see the closing for up to

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 really want to

How do you make the business case for MDR? You need to do a product portfolio rationalization. For some of your