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 In category: MDR Podcasts Regulatory Quality Videos
The Do’s and Don’ts of FDA Submission Pathways As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions In category: Regulatory Quality Videos
Choosing the Right FDA Pathway for Your Product, Component or Accessory Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by asking In category: FDA Approval Regulatory Quality Videos
FDA Approval of Your Medical Devices: There’s No Escaping It, Might as Well Accept It Acceptance: The Fifth Stage of Regulatory Grief (video) Let's face it - no one likes being told what to do, and In category: FDA Approval Videos
Why Medical Device Software is NOT Just Software Software is software is software, right? That's what Jose Bohorquez and I hear from medical device companies all In category: Regulatory Quality Videos
The Right Stuff? Ever wondered what it takes to be a regulatory and quality professional? 🤔 Think you have what it takes to In category: Regulatory Quality Videos
Ventilators, Components and Accessories – Oh My! Choosing the Right FDA Pathway for Your Product Ventilators are still a hot topic in the medical device industry, and there are still manufacturers working to bring new In category: Regulatory Quality Videos
Authorization vs Clearance vs Approval Can YOU explain the differences between FDA authorization, clearance and approval? 🤔 I hear people use the three In category: LinkedIn Submissions Videos
Changing the EUA Process for Masks – Again So, I was still up at 2am - again - trying to wrap my brain around the latest changes to the EUA process for surgical In category: Regulatory Quality Videos
Regulatory and Reimbursement: Two Great Tastes that Taste Great Together! You may not think that these two very different disciplines - regulatory and reimbursement - have much to do in relation In category: Regulatory Quality Videos