Medical Device Recall

Don’t Be Left in The Dark

Recalls Happen; We Can Help

  • We will help you properly notify the FDA, distributors, and customers of a recall.
  • We will guide you through generating compliant documentation to open, track, and close a recall.
  • We will help submit required monthly recall updates to the FDA.
  • We can perform recall effectiveness checks required by the FDA for recall closure.
  • We can teach you to write and submit recall closure letters.
Need help with Medical Device Recall?

Schedule a Free Consultation

Your journey to a successful regulatory submission and your LEAN Quality System begins here

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