"FMEA in Medical Device Lifecycle Management: Beyond the Basics"
Abstract
"Leveraging data analytics can elevate the traditional FMEA approach. By utilizing real-world data from clinical use, adverse events, and post-market surveillance, manufacturers can refine their FMEA process. Predictive modeling and machine learning can also identify hidden risks that may not have been considered in initial analyses, allowing for more precise risk mitigation."
Fields of Study & Subjects
Quality and Safety in Healthcare
Risk and Safety Analysis
Safety Systems Engineering in Autonomy
Publication details
- Journal / source
- IEEE DataPort
- Publication date
- 13 January 2026
- Document type
- Dataset