Extraction Expertise for Medical Device Chemical Characterization
EAG offers advanced expertise and a risk-based approach for medical device extractable study design and execution, including the latest FDA expectations.
EAG Expands Medical Device Testing Services
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).
Medical Device Laboratory Capabilities
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 biocompatibility 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; FDA-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.
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