Medical devices

According to the definitions of the medical devices directive, 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 Directive 93/42/EEC (MDD: Medical Device Directive; available at [»]) and the forthcoming Regulation (EU) 2017/745 MDR: Medical Devices Regulation; available at [»]) and corresponding to the series of DIN EN ISO 10993 standards.

Marketability can be certified by us due to our state authorized expert status.