Product Safety and Enterprise Risk Management in plain English. QPC provides you with a dedicated Product Safety Risk Management expert committed to your organization who walks you through the entire process.
With 15 years of experience in leading remediation projects, we know it's not easy fixing FDA regulatory compliance problems, but our well established approach will make it all clear and understandable.
Our primary focus is on the 510(K) Pre-market Notification Process. Our well established 510(K) Development and Submission process provides you with a clear road map from concept to clearance.