As of 2021-05-26, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) are history.

A very eventful year lies behind us. The Corona pandemic had a massive impact on all areas of life and is still not over yet.

On 25 April 2020 our designation under Regulation (EU) 2017/745 was published in the official European database NANDO

For legal manufacturers of medical devices we offer conformity assessment procedures according to Directive 93/42/EEC as a Notified Body.

For legal manufacturers of in vitro diagnostic devices we offer conformity assessment procedures according to Directive 98/79/EC as a Notified Body.

We offer certification according to ISO 13485 and ISO 9001 in the area of medical devices, in vitro diagnostic devices, pharmaceuticals and related areas.