FDA Post-Market Surveillance

Post-market

Before bringing your device to market, you went through a series of rigorous regulatory processes to get it approved for commercialization. But because some risks manifest over time, the U.S. Food and Drug Administration (FDA) requires post-market surveillance (PMS) of your device to ensure its continued safety and effectiveness in the real-world setting.

Post-market evaluation of your device can be time-consuming, cumbersome, and complex, presenting a challenge for many manufacturers. At Sterling Medical Devices, this is what we do—and we do it exceptionally well.

Sterling can help.

Our team of experts can help you create PMS and post-market follow-up (PMCF) plans and reports; integrate risk, clinical evaluation reports (CER), and PMS processes; and develop and execute on PMCF surveys and usability data.

We’ll also help you identify areas of negative impact to mitigate the risk of potential issues, then provide easily attainable avenues for remediation when necessary. Our remediation expertise includes:

• Meeting marketing and reporting requirements
• UDI support
• Import/export issues
• Inspection readiness and audits
• Compliance consulting and remediation
• Design History Files (DHF) and technical documentation remediation
• 483s, warning letters, untitled letters, recalls, off-label promotion, false claims, consent decrees, and global resolutions
• Gap analyses

At Sterling, we understand the legal requirements of the federal Food, Drug, and Cosmetic Act (FD&C) and related statutes enforced by the FDA. We also know the legal and regulatory requirements for medical product development, marketing approval, reporting requirements, inspections, and enforcement actions. When it comes to the increasingly complex world of post-market surveillance, follow up, and remediation, we’ve got you covered.