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Chemical Analysis

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Failure Analysis

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Mechanical & Physical Testing

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Medical Device

Hauser Laboratories is an innovative technical consulting organization that has assisted medical device manufacturers, designers, regulators, and attorneys. We provide services in support of activities such as claims validation, design verification, component substitution, failure investigation, complaint investigation, and litigation. We have a history of testing medical hardware, analyzing medical components, formulating medical products and providing failure analysis.

Hauser Laboratories is nationally recognized for its problem solving capabilities. Our materials specialists have a strong background in materials applications, uses and environmental effects on materials. In the medical device and diagnostic industries our expertise covers a broad range of consulting and testing services.

TESTING EXPERTISE

 

·  Material and Chemical Compatibility

 

·  Plastic Properties / Performance

 

·  Failure Analysis

 

·  Process Validation Consultation

 

·  Sterility Testing

 

·  Microbial Testing

 

·  Robustness / Sensitivity

 

·  Analytical Method Development

 

·  Materials Identification

 

·  Physical and Chemical Tests

 

·  Corrosion and Environmental Effects

 

·  Expert Testimony

 

·  Simulated / Service Testing

 

·  Product Re-Engineering

Hauser Laboratories is a full service physical and chemical testing laboratory with complete analytical instrumentation to serve our clients’ needs. Hauser has earned a reputation for providing customized, high quality solutions to meet clients’ requirements. We listen to your ideas, needs, and concerns to provide you with accurate evaluations and high quality services.

GMP medical device manufacturers can outsource the activities listed above to Hauser Laboratories in accordance with 21 CFR 820.50, with Hauser Laboratories considered to be an extension of the manufacturer's quality system.

EXAMPLES OF MEDICAL DEVICE PRODUCT EXPERTISE

  • Effects of Sterilization Processes on Mechanical Performances and Shelf-life of Catheters
  • Performance Verification of Drug Metering Pumps
  • Flammability Testing of Tracheotomy Tubes for Enriched-Oxygen Environment Service
  • Failure Analysis of Pacemaker Solder Joints
  • Compatibility of Surgical Instrument Coatings with Disinfectant Solutions
  • Simulated Service Life Testing of a Prosthetic Ankle Joint
  • Failure Analysis of Failed Welds from a CAT-Scan Machine Frame
  • Fatigue Life Testing of Check-Valves for Disposable Aspirators
  • Material Identification and Characterization for Component Substitution
  • Performance Testing to Demonstrate Equivalence for 510K Submissions
  • Scanning Electron Microscopy to Compare Stylette Tip Geometry and Finish
  • Investigations into Performance Differences between “Identical” Components, Materials and Devices
  • Identification of Foreign Material, Contamination, “Specks”, Inclusions, etc.

 

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