Medical Device

Medical Device

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.

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

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Medical Device Testing Services

Our facilities conduct medical device testing on:

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

Benefits of Choosing VARCHU MARC LLP 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