According to the definitions of the medical devices regulation (Regulation (EU) 2017/745, MDR), available at [»], the purpose of medical devices is to diagnose, prevent, monitor and treat diseases or injuries and to support changes in anatomic structure. Examples for medical devices are implants, laboratory diagnostics, x-ray apparatus, dressing material and protheses as well as incontinence products and surgical instruments.
We review the legal compliance and biological/toxicological innocuousness of medical devices by execution of a conformity assessment corresponding to Regulation (EU) 2017/745 (MDR; see above) and corresponding to the series of DIN EN ISO 10993 standards.
Marketability can be certified by us due to our state authorized expert status.