Case Study: Expedited Medical Device Certification

Case Study: Expedited Medical Device Certification

Eurofins E&E Delivers Expedited Medical Device Certification for High Priority Project

Eurofins E&E North America—the very first NRTL and a leading provider of testing, inspection, and certification services—was able to deliver expedited medical device certification for a high priority respiratory device instrumental in treating COVID-19 Coronavirus patients.

The medical device manufacturer submitted an urgent project amendment request to add alternate critical components. Most notably, the manufacturer needed to add a rechargeable battery pack to the device, which delivers heated and humidified respiratory gases to neonatal, pediatric, and adult patients.

Eurofins E&E North America strives to go above and beyond to deliver results for its customers. For this project, once the required documents were provided by the manufacturer, Eurofins E&E North America was able to draft, approve, submit, and release the certification package to the manufacturer in less than 24 hours.

Eurofins E&E North America received the following feedback from the manufacturer:

“Thank you very much … for the Sunday night review – unprecedented!  Thank you all for your tremendous support. Words cannot describe how much this means to (our company) and the patients we help.”


At Eurofins E&E North America, we treat your most important project as our most important project. We strive to be a true partner in the testing, inspection, and certification process rather than just a vendor.

We believe your product belongs in the marketplace, not in a test lab. That is why we work with our customers to get their products to market smarter.

Let us show you the Eurofins E&E difference. Contact us or call 410.354.3300 for more information.


Eurofins E&E North America is part of Eurofins Scientific, a leading international group of laboratories with about 45,000 employees across more than 800 sites in 47 countries. Eurofins provides an unparalleled range of testing and support services to the pharmaceutical, food, environmental, and consumer products industries, as well as to government entities.