Ventilators are still a hot topic in the medical device industry, and there are still manufacturers working to bring new ventilators to market.
I had the opportunity to answer questions about FDA pathways and requirements for a group of manufacturers, and there were a LOT of them.
The answers apply to more than just ventilators, so there is something in this video for just about everyone: https://youtu.be/e-UTXSFwHaw
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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Hitting the Regulatory Sweet Spot with Investors
Pitching to potential investors? You better have a solid regulatory strategy, because venture capitalists are becoming educated enough to ask
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FDA Reclassification of Blood Lancets
The recent reclassification of blood lancets by the FDA may or may not have caught you by surprise. To bring
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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:
