EAG Laboratories, a Eurofins company, is expanding its medical device testing capabilities with a new 20,000-sq.ft laboratory located in St. Louis, MO.
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The new laboratory is a bespoke design to support the requirements of the medical device industry. It increases EAG’s analytical capabilities, allows for improved turnaround times and helps meet evolving requirements from the FDA as well as the European Union Medical Device Regulations (MDR).
Specialty features of the laboratory include the following:
- A cleanroom designed for particle isolation and identification
- A dedicated medical device polymer analysis laboratory
- Instrumentation to support biocompatitility testing of ISO 10993-18 programs for medical devices and combination products.
The St Louis laboratory is ISO 9001:2015 and ISO 17025 accredited; FDA-registered and DEA Licensed, and offers materials characterization, failure analysis, particle identification, contaminant identification, analyte quantitation, and ISO 10993-18 chemical characterization.