Medical Device Recall

  • We’re here to support you in alerting the FDA, distributors, and customers about a product recall, ensuring clear and compliant communication.
  • Our expert guidance will help you create compliant documents essential for initiating, monitoring, and wrapping up a recall, streamlining the process.
  • We’ll assist you in providing the FDA with necessary monthly recall updates and keeping all stakeholders informed.
  • Our team can carry out the recall effectiveness checks as required by the FDA for successful recall closure, ensuring all standards are met.
  • We offer training on crafting and submitting recall closure letters, empowering you to handle future incidents confidently.