For medical devices and biomaterial companies, EAG Laboratories offers the most diverse and comprehensive suite of testing and engineering support available. From raw materials testing, R&D, GLP- and cGMP-compliant analytical services, to evaluations of manufacturing processes and product failures/returns, we help companies creating medical devices innovate, troubleshoot and protect their IP.
Our scientists have vast experience developing and evaluating materials and drugs used in medical devices, inhalation devices, pre-filled syringes, metallic and other implants, catheters, infusion pumps, vascular sealants, bio-polymers as well as a myriad of drug-device combination products. EAG Laboratories is FDA-registered and ISO 17025-certified.
How do you drive R&D productivity and at the same time keep pace with evolving regulations? Turn to EAG. WE KNOW HOW.
HOW WE CAN HELP
EAG offers the comprehensive suite of analytical and testing services:
- Materials & surface analysis: From metal oxide characterization for implants to surface chemistry for contact lenses, EAG has done it all. No scientific services company has more experience with the breadth of techniques used to characterize, test and assure purity of medical devices and their materials, components, products and packaging.
- Electronics testing: EAG offers engineering support for FA analysis and electronic troubleshooting, fault localization and root cause determination. Our electrostatic discharge (ESD) testing ensures that medical device chips will withstand electrostatic discharge events that may occur during handling and assembly.
- Chemistry, manufacturing & controls (cGMP): Comprehensive analytical support and quality control for devices and combination products under cGMP including analytical method development and validation; raw material and component testing; drug-device compatibility testing, IND-enabling, clinical, registration stability and post-marketing programs; reference standard management; QC release testing; and full extractables and leachables programs for products and product packaging
- Characterization of nickel rich alloys for biocompatibility: EAG has the full set of capabilities to characterize nickel rich alloys for biocompatibility consistent with FDA Guidance. The overall studies can include a combination of corrosion testing, nickel ion release and oxide layer thickness. We have extensive experience working with nitinol, MP35N and stainless steel alloys in a variety of shapes and geometries.
- Trace analysis & structural chemistry: polymer characterization, isolation, identification and characterization of trace impurities to support stability programs, degradation pathway studies, compliant sample testing, and product and process investigations
- Failure analysis: EAG scientists investigate device failures, including adhesion and bonding issues. We also have expertise solving problems of corrosion, oxidation and embrittlement. Our expert metallurgists can determine the location of failure as well as offer the root cause so a solution can be developed quickly.
- Consulting & litigation support: EAG maintains a team of scientists and engineers who provide technical consulting, problem solving and litigation support, including expert testimony for product liability and other cases.