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.
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 often
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Risk Management – Defining Hazards, Calculating Probability
Don’t panic! Even if you were traumatized by eighth-grade algebra and sent into full PTSD by 11th-grade AP calculus, you can handle risk management – I promise.
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Making the Business Case for MDR (or Whether It’s Worth Selling in Europe)
(Edited Transcript – link to the full presentation) How do you make the business case for MDR? You need
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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:
