Making the Business Case for MDR (or Whether It’s Worth Selling in Europe)

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

As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions

Acceptance: The Fifth Stage of Regulatory Grief (video) Let's face it - no one likes being told what to do, and

Software is software is software, right? That's what Jose Bohorquez and I hear from medical device companies all

Ventilators are still a hot topic in the medical device industry, and there are still manufacturers working to bring new

Can YOU explain the differences between FDA authorization, clearance and approval? 🤔 I hear people use the three

So, I was still up at 2am - again - trying to wrap my brain around the latest changes to the EUA process for surgical

You may not think that these two very different disciplines - regulatory and reimbursement - have much to do in relation

What do you say to your elderly neighbor when they show you the fraudulent N95 mask they bought online? Repeat after

At the 10x MedDev Conference in London, I spoke in detail about the regulatory definition of state of the art, comparing