Medical Device Testing

As the use of medical products like implantable parts and medical procedure devices has increased over the past few decades, we have been a pioneer in developing testing protocols to ensure that the products are safe. We have worked on catheters, ocular implants and lenses, heart valves, pacemakers, stents, synthetic joints, dental materials, and cosmetic implants (among other materials).

Projects included looking for residual solvents from cleaning operations, confirming the levels of active ingredients or purity of drug formulations, measuring the trace silicones that could leach from an implanted device, and contamination or failure analysis.

In addition, we are frequently utilized to support our clients’ research and development projects. We can help evaluate the implications of alternative materials and processes on the stability or purity of new products. Our data is commonly used in FDA submissions. We can provide services that are quick material confirmations and identifications as well as full validation studies. We can provide testing in conformance with Good Manufacturing Practices and Good Laboratory Practices and are amenable to external audits by our clients or regulators, as needed.