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

Punchline: The FDA EUA transition plans require all devices marketed under COVID enforcement policies or an EUA to

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

  (Edited Transcript - link to the full presentation) How do you make the business case for MDR? You need to

MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so. A few weeks ago, my

The recent reclassification of blood lancets by the FDA may or may not have caught you by surprise. To bring you up