Medical Device Testing Services
When intended for implantation in patients, medical device material quality is of the utmost importance. Failure to meet the rigorous standards of medical device OEMs can have devastating results for patients and their families. Ensuring your materials are made to your specifications and investigating failures promptly and accurately are both critical to meeting the medical industry's strict quality standards.
IMR Test Labs is an accredited materials testing lab providing analytical services to the medical device and dental industries. We have extensive experience working with medical OEMs to verify raw materials, handle overflow testing from internal labs, test finished products, and provide support to research and development efforts.
Our facilities conduct testing on metals, polymers, powders, coatings, ceramics, and finished products to support medical OEMs and their suppliers.
Medical devices intended for permanent implantation must meet stringent cleanliness standards to minimize the risk of post-surgery complications. To ensure the viability of such devices, their medical cleanliness must be determined before they can be used in practical applications.
IMR Test Labs is ready to help medical device manufacturers avoid the major risk of potential adverse reactions from contaminants on implants. We employ a wide array of medical device testing methods, from mechanical, metallurgical, and chemical testing of raw materials, to medical device coating evaluation through cytotoxicity and medical device cleanliness analyses.
Modern orthopedic and dental implant devices often incorporate porous coatings or structures that are designed to promote bone infiltration for biological fixation of the implant. These coatings are often subjected to shear stresses in normal use and the coating must not shear off under those stresses.
Test programs can be designed to determine the performance of these coatings under constant or cyclic application of shear stresses. Test samples are subjected to shear loads parallel to the surface plane in order to evaluate their strength and fatigue life properties. Fatigue testing methods can either be for developing S-N stress-life curves or for completing several run-out tests against predetermined acceptance criteria. Data from these tests can be used to satisfy regulatory requirements, as well as comparing/evaluating coating types and suppliers.
Click here for a complete list of accreditations and certifications for all IMR Test Labs locations
Hazardous Substance Testing
Heavy Metal Impurities
Particle Size of Powders
Total Organic Carbon
Trace Additive Analysis
Trace Element Analysis
Ca:P Ratio of Hydroxyapatite
3 Point Bend Fatigue
Coating Shear Fatigue
High Cycle Fatigue
Low Cycle Fatigue
Rotating Beam Fatigue
Bond Strength Testing
Coefficient of Expansion
Coefficient of Friction
Hardness (Brinell, Rockwell, Barcol, Durometer, Shore)
Passivation Testing for Stainless Steel (ASTM A967, QQ-P-416)
Beta Transus Determination
Intergranular Attack (IGA)
Intergranular Oxidation (IGO)
Microhardness (Knoop, Vickers, Macro-Vickers)
Root Cause Analysis
Stress Corrosion Cracking Susceptibility (SCC)
Thermal Spray Coating Analysis