Balda AG and Mechatronic AG present joint development

12. Oct. 2015

App-controlled drug dispenser

The Smart Drug Dispenser keeps track of tablets.

Madrid, October 12, 2015 – Patients will soon be able to dose their drugs via their smartphones. The medical technology companies Balda AG and Mechatronic AG present the Smart Drug Dispenser exclusively within the scope of the CPhI Worldwide in Madrid. The combination of app and easy-to-handle drug dispenser helps prevent administration errors and thus unnecessary complaints or hospital stays.Read More

Thomas Ullmann new member of the Medtec Europe advisory board

01. Oct. 2015

Darmstadt, 30 September 2015

Managing director of Mechatronic AG supports the further development of the medical technology trade fair.

Darmstadt – 30 September 2015. Thomas Ullmann from Mechatronic AG has become a member of the strategic advisory board of Medtec Europe. The speaker of the executive board of the medical technology company will be involved in defining the strategic guidelines for the future of Medtec. The 13-member committee will also discuss how the fair can be made more attractive for trade visitors. Drawing more than 6,000 visitors annually, it is Europe’s largest trade fair for development and manufacture in the medical technology field and a key rendezvous for experts.Read More

Mechatronic AG now recertified

16. Jul. 2015

Darmstadt, 7 July 2015

In the last week of June, Mechatronic AG passed a four-day recertification audit for the sixth time.

The medical technology company, based in Darmstadt, has been certified according to EN ISO 13485 and DIN EN ISO 9001 since 1997 and is thus subject to an annual monitoring audit as well as a recertification audit every three years.

“Especially in the field of medical technology, quality assurance is of particular significance. Thus, we will continuously further develop our quality management system in future as well in order to improve our internal processes, which will in turn result in increased customer and employee satisfaction,” said Thomas Ullmann, CEO.

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”.