Post-Market Surveillance
Stay Compliant, Improve Safety, and Strengthen Market Confidence
Our post-market surveillance services help you track device performance once the device is commercially available. Setting up the proper processes identifies emerging risks, and allows you to stay in front of compliance requirements.
H2: Why It Matters
Regulatory bodies require proactive post-market surveillance to monitor risk and performance of devices on the market. Without a system in place, you will default on compliance and put your device at risk for product recalls, and irreparable harm. We help you put the proper process in place to ensure your device and your business are protected and compliant.
Our Approach
We design and implement surveillance programs that align with FDA and EU MDR (Medical Device Reporting) requirements. We set up your processes to collect and analyze post-market data, manage customer feedback, and update your documentation as needed.
Our Post-Market Services Include:
Post-Market Surveillance
Complaint and Adverse Event Tracking & Reporting
CAPA (Corrective and Preventive Actions) Support
Clinical Evaluation Updates
Field Performance and Risk Monitoring
Reporting for FDA, EU MDR, and Global Regulatory Bodies
What You Get
A fully compliant, risk-mitigating market surveillance program that helps your product evolve, protects patients, and demonstrates your ongoing regulatory responsibility.