Chemical and Physical Analysis
From a diabetic infusion set to hip and knees implants, medical devices cover a very broad and complex variety of technologies. Since devices have a very broad spectrum of products, so are tests and testing requirements for safety. Eurofins Medical Device Testing has been assisting Medical Device customers with their developmental testing and regulatory submissions for over 30 years.
Our analytical chemistry laboratories are equipped with more than 500 chromatography systems and our highly trained chemists performed over four hundred extractable studies in 2016 alone.
Overview of our services
- Chemical Characterization (ISO 10993-12, 18, and 19)
- Identification and Quantification of Degradation Products (ISO 10993-13, 14, and 15)
- Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
- Residual Ethylene Oxide (ISO 10993-7)
- Material & Product stability
- Raw material purity
- Unaxial mechanical Testing
- Particle Size
If you would like more information about our Medical Device testing capabilities contact us or visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/