There is a HUGE difference between how the FDA will support you through a 510K submission and what your notified body can do to help you prepare for MDR certification, and I touch on that in this podcast with Monir El Azzouzi.
We also chat about FDA submission pathways, and how to use each one to your best advantage.
Mea culpa – in this podcast, I say that the typical timeline for a special 510K submission is 60 days. It is actually 30…I got my numbers mixed up while speaking.😕
Keep Those Masks Close at Hand, People : FDA Sets COVID Vaccine Effectiveness Threshold at 50%
Keep your fake and unregulated masks on, folks. These highly-anticipated vaccines ain’t necessarily gonna make the coronavirus go away. 😲
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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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Denial – Not Just a River in Egypt
It’s so easy to remain in an extended state of denial these days. 😒 COVID continues to wreak havoc on
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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:
