You’ve heard me tell you often enough that the first stage of regulatory grief is denial. And over the past two years, I’ve tried to explain just how much of an impact denial can have on your regulatory strategy.
In this video, Tianna Benson and I take it up a notch, and offer up real-world examples of how “we need ALL the features” syndrome and “We love our own science” disorder can REALLY screw up your submission.
There’s No Bargaining with the FDA
Bargaining with the FDA – or trying to – is the third stage of regulatory grief, but adopting that as
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FDA Submission for Combination Products
How do you determine the correct FDA submission for combination products? What IS a combination product? A combination product is
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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
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Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
