Submissions Archives | Regulatory + Quality Assurance | Michelle Lott | lean RAQA

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Intended Use or Indications for Use?

Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but

In category: FDA Approval Regulatory Quality Submissions

Authorization vs Clearance vs Approval

Can YOU explain the differences between FDA authorization, clearance and approval? 🤔 I hear people use the three

In category: LinkedIn Submissions Videos

You and FDA Sittin’ in a Tree

You and FDA are going to get pretty cozy before you are granted clearance – the 'marriage certificate' in our little

In category: LinkedIn Submissions