Mechatronic AG passes first FDA inspection

16. Jul. 2015

Darmstadt/Höhn, May 2015

In April, the U.S. Food and Drug Administration (FDA) carried out a four-day audit at Mechatronic AG’s production site in Höhn/Westerwald.

The routine inspection of the company, which develops and produces medical technology devices on behalf of its customers, serves to monitor compliance with Current Good Manufacturing Practice (CGMP) regulations (21 Code of Federal Regulations Part 820). During the course of the audit, the U.S. authorities not only inspected the production site, but also reviewed to what degree Mechatronic AG’s internal processes and procedures and its implemented quality management programme comply with FDA regulations regarding the development and production of medical devices. Mechatronic AG passed the audit without any deviations and is thus “FDA accepted”.


Fairs and exhibitions 2019

The First edition of MedtecLIVE exhibition willl take place in Nuremberg from 21 to
23 May 2019.

Mechatronic AG will be exhibiting at at this new fair which is a Fusion of Medtec Europe and MT-CONNECT

Visit us at our booth in hall 10.0, at stand 529!


Corporate Communications

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Fax: +49 6151 5003 – 170