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