FMEA Risk Management Series
Video 1 – Introduction to Failure Modes & Effects Analysis
An overview of Failure Modes & Effects Analysis (FMEA) and how it supports ISO 14971 and FDA expectations. Covers purpose, structure, and how FMEA strengthens risk-based decision making across device development.
Video 2 – Deep Dive Into FMEA Table Structure
A detailed walkthrough of the FMEA worksheet—failure modes, causes, effects, scoring, RPN calculation, and linking controls into the Risk Management File. Includes a mock example for practical clarity.