Medical devices

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.

Contact
claudia.wehrhahn@tox-consult.de
joachim.haselbach@tox-consult.de
natalia.jansen@tox-consult.de
edwin.efa@tox-consult.de