Diagnostic Devices TÜV certifies Ferchau branch to EN ISO 13485
TÜV Rheinland has certified the Electronics, Software, Medical Technology (ESM) technical office of the Mannheim branch of Ferchau Engineering to EN ISO 13485, confirming that it fulfils the statutory requirements for developing software for medical diagnostic devices.
Firmen zum Thema
Representing the branch, the quality management supervisor of the Able Group, Ralf Maasch (at right in the photo), took receipt of the certification document from Dr. Heiner Lüdemann of TÜV Rheinland. “With the certification to EN ISO 13485, Ferchau Engineering is not only documenting its high-quality claim on its own processes, but is at the same time making its entry into the medical technology service sector,” explained Dr. Heiner Lüdemann, a medical device expert at TÜV Rheinland.
In order to be able to offer pharmaceutical and medical technology companies complete systems from a single source in future, Ferchau Engineering took over the Mannheim-based company Konplan at the end of last year. Konplan was a specialist in microelectronic and software development for medical technology, among other things.
For further information:
Ferchau Engineering GmbH