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Regulatory + Quality Assurance | Michelle Lott | lean RAQA

  • Services
    • Regulatory Strategy
    • Regulatory Submissions
    • Quality Systems Compliance
    • Audits
    • Due Diligence
    • Technical Support
  • Industries
    • Medical Devices
    • Biologics
    • Drugs
  • Videos
  • About
  • FREE

FDA Medical Device Classification and the “Simple” Surgical Mask

As I have said before, there is nothing simple about surgical masks.

And now many companies seeking to manufacture or import surgical masks are finding that what they thought was a “simple” mask is actually subject to some very complex and detailed regulations.

To their dismay, they are also realizing that the EUA process is not an open ticket to market success. Or a get out of jail free card. 😉

In this video, I take a deep dive into the FDA regulatory wormhole, using masks as my example. There is also a brief foray into the EUA wormhole and some insight from a few knowledgeable friends, just to keep things interesting. Enjoy!

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Michelle Lott helps clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. Her expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
Winning in the marketplace!

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