Optimizing SaMD Complaint Handling
with Precise Defect Identification

As Software as a Medical Device (SaMD) adoption grows, teams are dealing with more complaints than ever.

But not every complaint points to a software defect.

Many issues come from user errors, configuration gaps, or system environments—yet they often get treated like product problems. This leads to unnecessary investigations, slower resolutions, and added pressure on engineering teams.

This whitepaper introduces a clear, structured way to separate true defects from non-defects—so teams can focus on what really matters.

Why It Matters

• Millions of device-related events are reported annually
• A large share originates from user, configuration, or environmental factors
• Yet many of these are still treated as product defects

What You'll Discover

• A practical framework to distinguish defects vs. non-defects
• Hidden challenges that make classification difficult in real-world environments
• How leading teams improve triage accuracy and efficiency
• Approaches to manage high-risk non-defect scenarios

Unlock the full whitepaper to explore a structured, risk-based approach to SaMD complaint handling.