Post-Market Surveillance

Turning Real-World Feedback Into Safer, Stronger Devices

Regulatory compliance doesn't end at launch. At PulseForward, we help you stay compliant and responsive with structured Post-Market Surveillance (PMS) and Corrective and Preventive Actions (CAPA) systems that meet the evolving expectations of the FDA, EU MDR, and ISO 13485.

We translate field data into meaningful product improvements—identifying risks, reducing recalls, and keeping your devices safe, effective, and trusted.

Our Post-Market Services Include:

• PMS Plan & System Setup
  Develop PMS plans, data collection strategies, and feedback loops tailored to your product portfolio and regulatory landscape.

• Complaint Handling & Vigilance
  Implement workflows and tools to efficiently process complaints, adverse events, and mandatory reporting to regulators like the FDA and EMA.

• Trend Analysis & Risk Reassessment
  Analyze data to detect early safety signals and integrate findings into ongoing risk management and usability engineering updates.

• CAPA Process Development & Execution
  Identify root causes and implement actionable corrections and preventive measures using a closed-loop, audit-ready CAPA process.

• Periodic Safety Update Reports (PSURs)
  Prepare and maintain structured EU MDR reports summarizing benefit-risk balance and field performance of your devices.

• Post-Market Clinical Follow-Up (PMCF)
  Design and manage real-world clinical data collection activities that support continued device safety and performance claims.

Why It Matters:

Post-market data is a window into your device’s true impact. With increasing regulatory scrutiny and customer expectations, your ability to respond proactively is critical. PulseForward delivers the systems, analysis, and technical insight to help you manage risk, maintain compliance, and continuously improve your devices long after launch.