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.😕
Design Controls and Risk Controls
Aren’t design controls and risk controls essentially the same thing? Uh, no. They are similar, but in the end, very
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Is MDR Certification Worth 5% of Your Revenue?
I posted about the costs of MDR certification last year, and warned companies that achieving certification would be a sizable
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What Doesn’t Kill You Makes You Stronger
Baptism by fire gets a bad rap, and rightly so. It can be a very stressful and ineffective way to
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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:
