SAXOCON provides expert toxicological support for all stages of the biological evaluation process of medical devices as described in the ISO 10993 standard series. We help clients appropriately document relevant chemical, physical and biological properties of medical devices and their materials of construction in order to address relevant technical and scientific requirements. Based on material constituents and results from chemical analysis of extracts, we identify associated toxicological hazards and evaluate the risk for adverse health effects under the intended application of the medical device.
We apply state of the art tools and methodologies to demonstrate the biocompatibility of medical devices and qualify acceptable risks associated with their intended use. We integrate the available physical, chemical, toxicological, clinical, post‑marketing surveillance data and relevant safety information from the scientific literature, in order to document risk assessments that satisfy relevant ISO standards in addition to conformity with the essential requirements of Regulation (EU) 2017/745 on medical devices.
Our toxicology services associated with medical devices and their risk management include:
- Biological Evaluation Plans and Reports
- Biological Tests and Chemical Characterisation Studies
- Material Screening and Toxicological Profiling
- Suitability Evaluation of Drug-Device Combination Products
For more info contact firstname.lastname@example.org or give us a call on +45 40 11 20 27