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
- Finished Products
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
Hazardous Substance Testing
Heavy Metal Impurities
Particle Size of Powders
Total Organic Carbon
Trace Additive Analysis
Trace Element Analysis
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)
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