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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

Nothing Simple About Surgical Masks

We will all agree that making masks is a hot business right now, but there is nothing simple about a surgical mask. With the recent surge in mask demand, it seems that everyone is jumping on board the let’s-make-a-mask boat.

It’s just a simple mask, right? How difficult can it be? Not nearly as simple as you might think.

While making the masks may be relatively easy, even a “simple” surgical mask has a list of regulatory requirements it must comply with in order to achieve FDA clearance.

In this quick clip, I review the myriad requirements for said simple surgical mask, and talk a little bit about what a manufacturer new to the mask-making biz would need to document in order to be in compliance.

https://leanraqa.com/wp-content/uploads/2020/04/Regulatory-Requirements-for-MSH-Masks.mp4
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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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