Commercialization Projects

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?