Medical Device Testing - Analytical Testing Services for Medical Device Manufacturers
 
Impact Analytical is a leading contract analytical laboratory that provides full-service testing support to the medical device industry for class I, II, and III devices through all stages of the product life cycle.  Our top-notch services will deliver quality results that are on-time, and on-budget.  For a complete list of our capabilities and to learn how we can support your testing needs please visit www.ImpactAnalytical.com/MedicalDevice.

Analytical Testing Services for Medical Device Manufacturers

Impact Analytical is a leading contract analytical laboratory that provides full-service testing support to the medical device industry for class I, II, and III devices through all stages of the product life cycle.  Our top-notch services will deliver quality results that are on-time, and on-budget.  

Our medical device testing services include:

• Leachable and Extractable Testing
• Medical Device Failure Analysis
• Material Characterization of medical device components and finished products
• Contaminant identification in raw material, process intermediates and finished products
• Raw material characterization for quality control
• Lifetime product stability of medical device products and components

Material Testing Services

We use state-of-the-art instrumentation to provide expert material testing services for physical and chemical compositional material analysis.  Material analysis is often required by medical device manufacturers to identify contaminants and confirm raw material.

Stability Testing Services

We provide stability and accelerated stability studies to evaluate stability and device shelf-life.  Stability testing can be performed in a variety of environments and can comply with FDA requirements.  Visit our website to learn more about our stability testing services.

Extractable and Leachable Testing Services

We provide extractable and leachable analysis on all types of devices and materials.  Extractable testing can be performed using customer supplied methods or can be developed in order to mimic the usage conditions of the device.

Failure Analysis Services

Failure analysis testing will provide you with a detailed report and information regarding a device or medical device part failure.  A failure analysis expert will lead the investigation utilizing advanced instrumentation to characterize the failure and determine the root cause. 

In addition to the services listed above, we provide a comprehensive suite of testing services for medical device manufacturers.  Analytical testing services include:  

Accelerated Stability Studies
Bisphenol-A (BPA) and DEHP Testing
Impurity and Contaminant Analysis
Material Property Measurement
Material Testing & Characterization
Mechanical Testing
Quality Control Testing
Residual Solvents and Detergents
Shelf Life Studies
Unknown Component Identification

State-of the Art Instrumentation & Laboratories
We operate in six laboratories that are each equipped with state-of the art equipment. 

Microscopy Testing Services

• Polarized Light Microscope
• Optical Microscopy
• Stereomicroscope
• Transmission Electron Microscope (TEM)
  • Scanning Electron Microscope (SEM)
• SEM-EDS Analysis

Molecular Characterization Testing Services

• 400 Mhz NMR
  • Carbon 13, Proton, Phosphorus, Silicon
• GC-MS (EI & CI)
• Direct Probe MS (EI & CI)
• LC-MS
• Direct Infusion ESI-MS
• Fourier Transform Infrared Spectroscopy (FT-IR)  (with ATR & Microscope)
• UV-Vis

Gas Separations Testing Services

• Gas Chromatography (GC)
• GC-FID
• GC-MS
• GC-TCD

Liquid Separations Testing Services

• LC-MS
• High Performance Liquid Chromatograph (HPLC)
  • CAD, RI, DAD, ELS, UV-vis, RI Detection
• Ultra Performance Liquid Chromatography
• Size Exclusion Chromatography/ Gel Permeation Chromatography (SEC/GPC)
  • RI & MALLS Detection
• Titration
  • Acid/Base
  • Karl Fisher

Thermal/Mechanical Properties Testing Services

• Differential Scanning Calorimetry (DSC)
  • Modified & Pressure
• Thermogravimetirc Analysis (TGA)
• Thermal Mechanical Analysis
• Mechanical Testing
  • Tensile Strength
  • Izod Impact

Elemental Analysis Services

• Inductively Coupled Plasma (ICP-OES)
• Atomic Absorption (AA)