Defect Management in SaMD — From Chaos to Control

Medical Device made Easy Podcast · Feb 19, 2026

In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.

This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.

We cover:

Understanding Defects in SaMD

• What defines a defect in a regulated context

• How defect management differs from non-medical software

• The relationship between defects, risk management, and ISO 14971

Building a Compliant…