The Post-Brexit Medical Device Legislation is Here! Clear some space on your regulatory bookshelf! You’re going to need room for your copy of the UK’s newly-ado... In category: LinkedIn Regulatory Quality
FDA Submission Types, Costs and Timeframes – Which is Right for You? Very few days go by without someone asking me to explain the differences between FDA submission types. This most often c... In category: FDA Approval LinkedIn Regulatory Quality
FDA Submission for Combination Products How do you determine the correct FDA submission for combination products? What IS a combination product? A combination p... In category: FDA Approval LinkedIn Regulatory Quality
How to Help Overturn FDA’s Harmful Down-Classifications FDA made it easier to commercialize 91 risky medical devices. You can help reverse the ruling: 2 easy steps, 5 minutes. ... In category: Regulatory Quality
Choosing the Right Predicate Device: Apples and Oranges How do you go about choosing the right predicate device? Say you’ve developed a new tree-borne fruit and you need ... In category: FDA Approval LinkedIn Regulatory Quality
Intended Use and Indications for Use – NOT the Same Thing at All. Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but... In category: FDA Approval Regulatory Quality Submissions
Notified Bodies and Remote Audits, with a Little Help from the EC Let’s start the day with some much-needed good news from the EC. They’ve released a new guidance aimed at ma... In category: LinkedIn Regulatory Quality
Bad Design Controls are to Blame Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone depress... In category: FDA Approval LinkedIn Regulatory Quality
The Battle Rages On Quality vs. development vs. sales – It’s a story as old as time. Or at least as old as medical device regula... In category: LinkedIn Regulatory Quality
You Can’t Bargain Your Way Out of Regulatory Grief Bargaining is the third stage of regulatory grief, but you can’t bargain with the FDA. When dealing with the FDA, ... In category: Regulatory Quality
