How a Medical Device Team Fixed an EMC Risk Before Final Testing

EMC issues are often created during design but discovered during testing. This case-study style blog explains how early EMC review can help medical device teams reduce risk before final certification testing.

A medical device engineering team was preparing for final EMC testing. The product had already passed internal design reviews, the prototype was functional, and the launch timeline was tight.

Then the pre-compliance results showed a problem. The device was producing unexpected radiated emissions that could put the final IEC 60601-1-2 test at risk.

As one engineering lead described it: “We thought the design was ready for the lab. The issue was not obvious until we looked at the system from a compliance perspective.”

The issue

The problem was traced to a combination of cable routing, grounding, and insufficient filtering on a key interface.

None of these design choices looked like major risks individually. But together, they created an EMC issue that could have caused a failed test, redesign, and launch delay.

The team needed to understand:

• Which design elements were creating the risk
• Whether the fix would require a PCB redesign
• How the change would affect the certification path
• What documentation would need to be updated

How the issue was fixed

The team started with a focused EMC risk review before entering full certification testing.

The review identified the likely emission paths and prioritized fixes that would reduce risk without forcing a major redesign.

The corrective actions included:

1. Reviewing the cable layout and shielding strategy
2. Improving grounding continuity
3. Adding filtering to the affected signal path
4. Updating the technical documentation to reflect the change
5. Running another pre-compliance check before final lab testing

By addressing the issue early, the team avoided discovering the failure during formal testing.

The result

The final design moved forward with a clearer compliance strategy and fewer unknowns.

The biggest benefit was not just fixing the EMC issue. It was understanding the certification impact before the product reached the lab.

Key lesson

EMC issues are often created during design, but discovered during testing. That is what makes them expensive.

When engineering teams evaluate EMC risk earlier, they can make better design decisions, reduce rework, and protect their launch schedule.

At CertPath, we help medical device teams identify certification risks before they become costly test failures.