Intertek QTI

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

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Chemical Analysis for Medical Device Components

Medical device chemical analysis and testing.

Intertek chemical analysis expertise supports the medical device industry throughout the value chain. Intertek laboratories help medical device designers, developers and manufacturers with world-class data provision, problem solving and consultancy. Intertek delivers scientific support used for regulatory submissions while remaining flexible to deliver against rapid problem solving, manufacturing quality control and internal medical device component Research and Development requirements.  

Medical Device Components Chemical Testing includes: 

  • Identification of Extractable and Leachable chemicals 
  • Forced Degradation Studies and Degrade Characterisation 
  • Determination of API Drug Release Characteristics 
  • Stability studies including Accelerated and Stressed 
  • Imaging of the phase distribution of Drug Components 
  • Chemical and bio-analytical Characterisation of Proteins, Peptides and Macromolecule Therapeutics 
  • Specialist Surface Analysis 
  • Pharmaceutical Method Development Validation and Transfer  
  • Integrated Study Management, Pre-clinical and Stage 1 
  • GLP Pharmaceutical,  Bio-analytical and Immunochemistry investigations 
  • Pharmacopoeia Testing for Quality Control 
  • Medical Device Polymer Materials Testing 

 

to see how Intertek can help your organization with Chemical Analysis for Medical Device Components.