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
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
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Regulatory Depression? Bad Design Controls are to Blame
Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone depressed. But if your incomplete
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Regulatory and Reimbursement: Two Great Tastes that Taste Great Together!
You may not think that these two very different disciplines – regulatory and reimbursement – have much to do in
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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:
