The Top 10 Calibration Pain Points Hurting Medical Device Quality

Why calibration gaps lead to audit findings, batch holds, and delayed product release, and how manufacturers are addressing them.

In medical device manufacturing, calibration directly affects product quality, regulatory compliance, and patient safety. When calibration requirements are unclear or documentation is fragmented, minor issues can quickly escalate into inspection findings, out-of-tolerance investigations, and release delays.

This eBook examines the most common calibration pain points facing FDA-regulated medical device manufacturers and explains how disciplined calibration programs reduce risk and support predictable release readiness.

Common Calibration Challenges

Medical device teams often struggle with:

• Documentation gaps that increase audit stress
• Traceability breakdowns across suppliers and contract manufacturers
• Batch holds triggered by out-of-tolerance events
• Limited visibility into instrument status across R&D and manufacturing
• Growing complexity of test and measurement systems

The eBook explains why these problems occur and how leading manufacturers address them.

What You’ll Learn

• Where calibration programs break down and why
• How traceability and uncertainty are evaluated during inspections
• What drives lengthy investigations after OOT events
• How improved visibility and documentation support faster release decisions

Download the eBook to identify the calibration pain points affecting medical device quality and learn how to address them.