Our Accreditations, Facilities, and Equipment
Our Philadelphia facility is proudly recognized as an ISO 17025 accredited laboratory (A2LA Certificate 2561.01). Additionally, the laboratory is fully compliant with CFR 21 Part 58, U.S. FDA Good Laboratory Practices (GLP).
Mechanical and Durability Testing Facility
Biomaterials, medical devices, cadaveric, and animal models
The mechanical testing facility is equipped with servo-hydraulic load frames (displacement range: microns to millimeters, load range: millinewtons to kilonewtons) and electromechanical frames (displacement range: millimeters to centimeters, load range: millinewtons to kilonewtons).
The lab offers customized durability test equipment dedicated to evaluating coronary and peripheral stents as well as heart valves. Our custom small-force, small-displacement load frames are used for testing applications requiring gram-force and micron-displacement resolution.
We have capabilities to functionally evaluate spinal, cardiovascular, and orthopaedic technologies; assess the durability and perform wear testing of these devices; conduct accelerated aging protocols; and use cadaveric models to evaluate medical device technologies.
Biosafety Level 2 Suites
Specimen storage, dissection, and procedure suite, including fluoroscopy
This facility contains a full-service cadaveric storage, dissection, and procedure suite to prepare tissues for evaluation of medical technologies. The suite is equipped with a fluoroscope, a tissue band saw, and all the necessary universal precautions and disposables needed to carry out cadaver-related activities.
The lab is also equipped with freezer and refrigerator storage for both human and animal samples. Exponent conducts all its cadaveric testing using IRB reviewed tissue collection and test protocols.
Optical microscopy, surface interferometer, FTIR, microCT, access to ESEM
The microscopy facility has digital imaging microscopes with a variety of lighting options, as well as macro- and microscopes with wide ranges of resolution and fields of view. This includes environmental scanning electron microscopy complete with elemental analysis (EDS). In addition, we have surface interferometry and FTIR spectrometry, complete with microscope and ATR attachment.
Exponent staff has access to area academic SEM and ESEM facilities. Access to microCT, MRI, X-ray, CT, and SEM/EDS facilities is also available through local academic and regional third-party labs and remote-view systems in other Exponent labs.
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Exponent's Philadelphia laboratory successfully completed the A2LA evaluation process and is ISO accredited. Our lab is certified to test medical grade plastics, metals and biomaterials, medical consumables, tissues, and medical devices in conformance with the U.S. FDA Good Laboratory Practice (GLP) Regulations.
Our lab is certified to perform the following tests: