Medical Device Testing Services

Medical device testing to ensure material quality is of the utmost importance, particularly since medical devices are permanently implanted into patients.  Failure to meet the rigorous standards of medical device OEMs can have devastating results for patients and their families. 

Testing of  medical implants, surgical instruments, trauma implants, medical sutures,  or coatings help ensure vendor materials are manufactured to your specifications. In addition, investigating failures promptly and accurately, are both critical to meeting the medical industry's strict quality standards.

Medical devices, instruments, and, in particular, orthopedic implants, come in direct contact with healthy human cells. In vitro testing methods allow technicians to evaluate these tools — and their materials — and efficiently assess their potentially toxic effects without any risk to animals or humans. This analysis can be combined with further evaluations to help determine overall biocompatibility and identify contaminants.

Accredited Medical Device Testing Services

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 in order to perform the following medical implant tests:

  • verify raw materials
  • handle overflow testing from internal labs 
  • test finished products 
  • provide support to research and development efforts

Medical Device Testing Services

Our facilities conduct medical device testing on:

  • Metals, Alloys, Precious Metals
  • Polymers
  • Ceramics
  • Finished Products
  • Powders
  • Coatings

IMR Test Labs medical device testing is performed for manufacturers and their suppliers, to mitigate major patient health risks of potential adverse reactions from contaminants on implants.

To ensure the viability of permanent implants, and minimize post-surgery complications, their medical cleanliness must be determined before they can be used in practical applications. 

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, of which the coating must withstand.

Data from these tests can be used to satisfy regulatory requirements, as well as comparing/evaluating coating types and suppliers.

Benefits of Choosing IMR Test Labs for Medical Device Testing Services

Efficiency - with 3 domestic locations and 2 Asian labs, we can test medical devices anywhere in the world quickly and efficiently.

Reporting - our comprehensive analysis includes accurate test results, and relevant analysis

Expertise - a leader in the medical device testing field for over 25 years

Scope - performing 20+ types of medical tests, selected and designed to your exact testing needs

Compliance - nationally accredited by A2LA to ISO 17025 standards, as well as certifications from many manufacturers

Instruments - state of the art equipment regularly calibrated to manufacturer standards

Types of Medical Devices Analyzed

  • Knee Replacements
  • Hip Replacement Implants
  • Spinal Implants
  • Dental Implants

Types of Medical Device Testing

  • Chemical Analysis
  • Fatigue Testing
  • Mechanical Testing
  • Transcatheter Mitral Valve Axial Fatigue Testing
  • Material Verification
  • Cleanliness - Organic/Polar Residues, Total Organic Carbon
  • Metallurgical Analysis
  • XRD Analysis

Fields of Testing

  • Orthopedic
  • Surgical
  • Dental

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

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

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

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

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

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
Microhardness (Knoop, Vickers, Macro-Vickers)
Plating Thickness
Root Cause Analysis
SEM Analysis
Stress Corrosion Cracking Susceptibility (SCC)
Thermal Spray Coating Analysis
Weld Evaluation

Print Friendly, PDF & Email