Pujitha Priyadarshini

Day 2, February 24, 2026

2:30 PM Track A: Workshop: Closing the Loop: Integrating Field Service Data into Medical Device Risk Management

Field service teams are often the first to detect emerging risks in medical devices through part replacements, service calls, and failure investigations. Yet this rich data stream is frequently underutilized in formal risk management processes. This session explores how to bridge that gap by embedding field service insights into the ongoing evaluation of device safety and effectiveness.

Drawing from real-world experience in risk strategy for infusion platforms, we’ll examine how service data such as frequency of component replacements, root cause investigations, and field service trends can be mapped back to existing risk control measures and design assumptions. We’ll discuss how to assess whether controls remain effective post-market, and how to update risk profiles in alignment with ISO 14971 and FDA expectations.

Attendees share and discuss practical strategies for:

Structuring field service feedback into risk management files
Identifying signals that may indicate degraded or insufficient controls
Collaborating across quality, engineering, and service teams to close the loop
Leveraging digital tools to automate traceability and capturing evidence

By integrating field service intelligence into the risk management lifecycle, organizations can proactively mitigate hazards, strengthen regulatory confidence, and deliver safer, more resilient medical devices to patients.

Field Service Medical 2026

Day 2, February 24, 2026

2:30 PM Track A: Workshop: Closing the Loop: Integrating Field Service Data into Medical Device Risk Management