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 2018

Compamed 2018

Mechatronic AG will again attend the Compamed, Düsseldorf, from November 12 to 15, 2018. About 800 exhibitors are expected to this fair for medical technology suppliers being held in parallel to MEDICA, the world´s leading medical trade fair (over 5,000 exhibitors). Last year a total of 125,000 specialist visitors from around 120 countries toured both fairs in Düsseldorf.

Visit us at our booth in hall 08B, at stand 8BH03!


Corporate Communications

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