The Five Steps to Market: FDA Product Code and Testing Plans Today we're talking about the third step in the five steps to market process - determining the right class and pathway In category: FDA Approval LinkedIn Regulatory Quality Submissions
The Five Steps to Market: Define the Product Can you name the five steps to market required to move your product from concept to launch? Obviously, we're talking In category: FDA Approval LinkedIn Regulatory Quality Submissions
The Regulatory Rockstar Movement: A Conversation with Michelle Lott This conversation is part of Arazy Group Consultants' Regulatory Rockstar Movement, which I was invited to participate In category: About Michelle LinkedIn Regulatory Quality
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
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