Post-Market Regulatory Compliance requirements

  • Instructions for Use
  • Labeling / Marketing Materials
  • Letters to File / Special 510(k)
  • Annual Submission Update Reports
  • PMA Supplements
  • Amendment Submissions
  • Vigilance Reporting (MDR/MDV)

Post-Market Quality Compliance requirements

  • Complaint Handling vs. Customer Feedback (improvement requests)
  • CAPA / NCR Management
  • Failure Analysis / Root Cause Investigations
  • Management Review Metrics

Neozene, as your Commercialization partner can help you answer the following questions:

  1. What is the difference between a 510(k) and a PMA?
  2. I have been told that I have to file for an IDE; what do I need to do?
  3. Why do I need to send supplemental reports on my PMAs every year?
  4. Do I have to report complaints from Germany to the FDA?
  5. How do I find the root cause of a product defect?
  6. What do I report to Management Review and how do I report it?
  7. What is the difference between a customer comment and a customer complaint?
  8. Do I have to investigate every complaint that my company receives?