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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 Device Cleanliness Testing

medical-device-cleanliness-hip

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.

 

Medical Device Coatings Testing and evaluation

Coating Shear-600Modern 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.

 

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RELEVANT ACCREDITATIONS

Click here for a complete list of accreditations and certifications for all IMR Test Labs locations

 

CHEMICAL ANALYSIS

Alloy Chemistry/PMI
Chemical Resistance
Chromium Analysis
Contaminant Analysis
DSC Analysis
FTIR Analysis
Hazardous Substance Testing
Heavy Metal Impurities
ICP Analysis
Ionic Contamination
OES Analysis
Particle Size of Powders
Polymer Analysis
Sieve Analysis
Surface Cleanliness
TGA Analysis
Thermal Analysis
TMA Analysis
Total Extractables
Total Organic Carbon
Trace Additive Analysis
Trace Element Analysis
Wear Debris
XRF Analysis

XRD Analysis

Ca:P Ratio of Hydroxyapatite
Percent Crystallinity
Phase Identification
Powder Morphology

 

FATIGUE TESTING

3 Point Bend Fatigue 
Axial Fatigue 
Axial/Torsional Fatigue 
Coating Shear Fatigue 
High Cycle Fatigue 
Low Cycle Fatigue 
Rotating Beam Fatigue

MECHANICAL TESTING

Bond Strength Testing
Coating Adhesion
Coefficient of Expansion
Coefficient of Friction
Compressive Properties
Flexural Properties
Hardness (Brinell, Rockwell, Barcol, Durometer, Shore)
Impact Testing
Tensile Testing

Corrosion Testing

Passivation Testing for Stainless Steel (ASTM A967, QQ-P-416)

 

METALLURGICAL ANALYSIS

Alpha Case
Beta Transus Determination
Carbide Rating
Case Depth
EDS/EDX Analysis
Failure Analysis
Grain Size
Inclusion Rating
Intergranular Attack (IGA)
Intergranular Oxidation (IGO)
Machining Evaluations
Metallography
Microhardness (Knoop, Vickers, Macro-Vickers)
Microstructure
Plating Thickness
Root Cause Analysis
SEM Analysis
Solderability
Stress Corrosion Cracking Susceptibility (SCC)
Thermal Spray Coating Analysis
Weld Evaluation