Business Wire07.12.21
EAG Laboratories is expanding its medical device testing capabilities with a new 20,000 square-foot laboratory located in St. Louis, Mo.
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:
EAG scientists have been investigating and resolving product failures for more than half a century and have a deep understanding of materials and testing procedures. The medical device laboratory expansion allows EAG to leverage that knowledge and apply it toward supporting the growing and vitally important medical device industry.
The St. Louis laboratory is ISO 9001:2015 and ISO 17025 accredited; U.S. Food and Drug Administration-registered and DEA Licensed, and offers analytical support in terms of materials characterization, failure analysis, particle identification, contaminant identification, analyte quantitation, and ISO 10993-18 chemical characterization.
EAG Laboratories is the global leader in materials and engineering sciences and supports thousands of clients with 20-plus locations throughout Europe, Asia, and the United States. EAG Laboratories’ parent company, Eurofins Scientific, is a multi-billion global leader in scientific testing services with a portfolio of over 200,000 validated analytical methods. With more than 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
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:
- A cleanroom designed for particle isolation and identification
- A dedicated medical device polymer analysis laboratory
- State-of the-art instrumentation to support biocompatitility testing of ISO 10993-18 programs for medical devices and combination products
EAG scientists have been investigating and resolving product failures for more than half a century and have a deep understanding of materials and testing procedures. The medical device laboratory expansion allows EAG to leverage that knowledge and apply it toward supporting the growing and vitally important medical device industry.
The St. Louis laboratory is ISO 9001:2015 and ISO 17025 accredited; U.S. Food and Drug Administration-registered and DEA Licensed, and offers analytical support in terms of materials characterization, failure analysis, particle identification, contaminant identification, analyte quantitation, and ISO 10993-18 chemical characterization.
EAG Laboratories is the global leader in materials and engineering sciences and supports thousands of clients with 20-plus locations throughout Europe, Asia, and the United States. EAG Laboratories’ parent company, Eurofins Scientific, is a multi-billion global leader in scientific testing services with a portfolio of over 200,000 validated analytical methods. With more than 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
