Medical Device Testing Services

From routine production support to failure analysis and litigation expertise, IMR's team of experts are well-qualified to deliver the answers you need.

 

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 TESTING SERVICES

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.

For a complete testing partner with superior customer service, contact us and let's start a conversation about your project or product testing needs.

 

Medical Device Coatings Testing and Analysis

Photo Dental

Fueled by extensive research and development efforts, the medical device industry is experiencing rapid growth. These initiatives are extending the life of medical devices, subsequently lowering patient risk by reducing replacement procedures. As such, device longevity is crucial to improving quality of life for patients. The coatings used to protect medical devices provide numerous benefits, such as:

  • Extended wear
  • Biocompatibility
  • Corrosion resistance

The highly-trained staff at IMR Test Labs has the expertise necessary to test any coating, plating, or paint to ensure suitability for medical device applications. Our full range of testing services includes x-ray diffraction, compositional analysis, metallography, and more. Contact us or request a quote to discuss your coatings and how we can determine their suitability for use on medical devices.

eBook Download Offer – Guide to Mitigating Biocompatibility Risks in Medical Device Manufacturing

Ebook

The medical devices and surgical tools used daily in the medical industry are subject to strict testing standards dictated by the FDA and other regulatory bodies using ASTM and ISO methodologies. Ensuring that these items are free from harmful residues left behind by manufacturing or cleaning processes is essential to maintaining patient health. As such, medical device manufacturers must carefully test the materials they use and the products they fabricate to make sure they are safe for biological contact with patients.

For more information on the importance of biocompatibility and cytotoxicity testing, click here to download our free eBook, “Mitigating Biocompatibility Risks in Medical Device Manufacturing.”Visit Our Blogs about Medical Cleanliness

A Guide to Medical Coating Evaluations

Medical device coatings help to ensure corrosion protection, lubricity, bone infiltration, and enhanced durability. When choosing a specific type of coating, it’s critical to select a solution that offers the right properties for the job to maximize the benefit to your device and ensure optimal part performance. Read more.

The Importance of Cytotoxicity Testing

In the medical industry, contamination is more than an inconvenience—it can be deadly. In order to ensure top biocompatibility performance from medical devices, tools, and implants, testing labs have developed a long list of diverse analytical methods to identify potential threats. These processes support the research and practices that create medical marvels every day. Read more.

 

Testing Services Available from IMR Test Labs

 

CHEMICAL ANALYSIS

Alloy Chemistry/PMI
Chemical Resistance
Chromium Analysis
Contaminant Analysis
DSC Analysis
FTIR Analysis
GC/MS (Pyrolysis, Thermal Desorption)
Hazardous Substance Testing
Heavy Metal Impurities
ICP Analysis
Ionic Contamination
OES Analysis
Particle Size of Powders
Polymer Analysis
RoHS Testing
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

 

 

IMR Test Labs – Accreditations

Ithaca, New York

Louisville, Kentucky

Portland, Oregon

Singapore

Suzhou, China

 

 

Medical Device Knowledge Sheet

Would you like to learn more about our processes and ethics at IMR Test Labs? If you’d like a summary of IMR Test Labs’ capabilities and general information including testing methodologies, contact information, and our company philosophy regarding testing and analyses of medical device assessments, download a PDF copy of our knowledge sheet here.

 

MEDICAL DEVICE KNOWLEDGE SHEET

Additional Free Downloads

IMR Services List

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

Medical Device Testing Services

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

Fatigue Testing Services

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

Failure Analysis & Litigation Services

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

Corrosion Testing Services

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

Cleanliness Testing Services

We are your one-stop laboratory for high quality materials testing services on metals, polymers, and composites.Read more.

 

Contact IMR Test Labs for All Your Medical Device Testing Needs

For more than 20 years, our dedicated team of engineers, chemists, lab technicians, and support personnel has been providing metal and non-metallic testing services and expert analysis for customers in the medical device industry.

With three labs in the U.S. and two in Asia, IMR Test Labs is ready to help you solve your most complex materials testing challenges. Visit our website or request a quote to learn more about how we can help certify the safety and cleanliness of your medical devices.

Would you prefer to talk to a member of our team directly? Call us at 888-464-8422 to discuss your testing needs.

Thank you for taking the time to learn more about IMR Test Labs. Not just data, knowledge.

 

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