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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