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.
Schedule a Free Consultation
Your journey to a successful regulatory submission and your LEAN Quality System begins here