CMG Helps Medical Device Manufacturer Resolve EMC Product Testing Failures in the U.S. and Europe
A global medical device manufacturer experienced electromagnetic compatibility (EMC) failures for its new bioreactor unit at test laboratories in both the United States and Europe. Unfortunately, these testing laboratories ━ over dependent on automation and lacking internal engineering expertise ━ were unable to assist with resolving the failures.
As compliance to the relevant national standards is required for worldwide sales (in this case, FCC and European Union standards), the manufacturer’s distribution plans were brought to a halt and the organization faced a substantial loss of revenue.
Avoiding a Product Redesign, Months of Delays, and Projected Revenue Losses
The manufacturer contacted the Compliance Management Group (CMG) upon learning of its design expertise in EMC mitigation. Within three days, CMG engineered a solution that feasibly relocated the unit’s internal components and avoided a complete product redesign. Once implemented, the unit passed both FCC and European Union electromagnetic compatibility standards and avoided significant supply-chain disruptions as well as hundreds of thousands in lost revenue.