Partner with our team to perform medical device testing to establish your product’s functionality and safety. Our services span the product lifecycle, whether your project is in development or has reached commercialization. We also support combination products by applying our broad range of experience in drug development. From method development through validation and monitoring, trust our team to offer the expertise needed to advance your project.
Device materials and manufacturing processes must be biocompatible to meet regulatory requirements. Our team conducts chemical characterization by identifying and quantifying the chemical components present in your materials. Then, we conduct a biological risk analysis, considering the intended applications, to inform our toxicological understanding. Partner with us to navigate biocompatibility testing for medical devices under ISO 10993 and other standards to advance with confidence.
Demonstrate your medical device’s safety, efficacy, and quality control with our support. Our team is highly experienced in a wide range of devices, microorganisms, and custom testing procedures to provide various services, such as:
Bioburden Testing
Biological Indicator Testing
Sterility Testing
Endotoxin Testing
If your device requires terminal sterilization, our services help satisfy stringent requirements by demonstrating the sterilant is removed from the product and packaging. We are highly trained in quantifying ethylene oxide (EO) and the common degradants, such as ethylene chlorohydrin (ECH) and ethylene glycol (EG).
Our labs are FDA and DEA registered, cGMP compliant and ISO/IEC 17025 accredited.
Ready to Get Started? Connect with our team to discuss quality testing services.