Chemical Analysis for Medical Device Components

Intertek chemical analysis expertise supports the medical device industry throughout the value chain. Intertek scientists 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 Degradation Product Characterisation
• Determination of Active Pharmaceutical Ingredient (API) Drug Release Characteristics
• Stability studies including Accelerated and Stressed
• Imaging of the phase distribution of Drug Components
• Chemical and bio-analyticalCharacterisation of Proteins, Peptides and Macromolecule Therapeutics
• Specialist Surface Analysis and Surface Imaging 
• Pharmaceutical Method Development and Validation
• Integrated Study Management, Pre-clinical and Stage 1
• GLP Pharmaceutical,  Bio-analytical and Immunochemistry investigations 
• Pharmacopoeia Testing for Quality Control
• DEHP and BPA Testing for Health Canada Medical Device Licencing
• RoHS Testing Services