Software, Heart Pumps and an FDA Warning Letter Imagine, if you will, an established medical device player and their newly-acquired subsidiary trying to flex their In category: FDA Approval LinkedIn Regulatory Quality Submissions
Design Controls and Risk Controls Aren't design controls and risk controls essentially the same thing? Uh, no. They are similar, but in the end, In category: Regulatory Quality
Cloud Computing and Medical Devices – and AWS? I recently caught up with my buddy Randy Horton over at Orthogonal, and we did a deep dive into the evolving landscape In category: Podcasts Regulatory Quality
QMSR and ISO 13485: Similar but Different In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO In category: ISO-13485 LinkedIn Regulatory Quality
Don’t Ignore Your FDA Submission Strategy Clients find lots of creative ways to ruin their FDA submission strategy. Doing their own research is one, and huge In category: Regulatory Quality
Risk Management – Defining Hazards, Calculating Probability Risk = 𝙎𝙚𝙫𝙚𝙧𝙞𝙩𝙮 of harm x 𝙥𝙧𝙤𝙗𝙖𝙗𝙞𝙡𝙞𝙩𝙮 of occurrence of harm Don't panic! Even if you were traumatized by eighth-grade In category: Regulatory Quality
Is MDR Legislation or Interpretation? Remember what I said about MDR no longer being legislation but interpretation? Here's another example for you: My In category: MDR Regulatory Quality
Biocompatibility and the FDA Bouncer The FDA's biocompatibility bouncer will get you every time, no matter how many times you try to sweet-talk your way In category: Regulatory Quality
More Reasons Not to Sell Your Product in Europe (This is an edited transcript of the video clip, but here's the link to the full presentation)Do you really want to In category: Regulatory Quality
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