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
Magic, Madness, MDR and Miniature Dollhouses MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so. A few weeks ago, my In category: LinkedIn MDR Regulatory Quality
Why You Need a Document Control Process Why do we need a document control process? Oh, if only I had a nickel for every time I've been asked that question. In category: 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 In category: FDA Approval 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 In category: FDA Approval LinkedIn Regulatory Quality
Choosing the Right Predicate Device: Apples, Oranges, or Something in Between? How do you go about choosing the right predicate device? Say you've developed a new tree-borne fruit and you need to In category: FDA Approval LinkedIn Regulatory Quality
Deregulation of Medical Devices: Say It Ain’t So! You KNOW your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to In category: FDA Approval LinkedIn
Post-Brexit Medical Device Legislation Clear some space on your regulatory bookshelf! You're going to need room for your copy of the UK's newly-adopted In category: LinkedIn Regulatory Quality
Medical Device Regulation and Ye Olde Snake-Oil Salesman Blame the snake-oil salesmen. It's mostly their fault that we ended up with so much medical device regulation in the In category: LinkedIn Regulatory Quality
COVID-Era Remote Audits, Notified Bodies, and the EC Let's start the day with some much-needed good news from the EC. They've released a new guidance aimed at making it In category: LinkedIn Regulatory Quality