More than 70 representatives from the medical device industry met in Cologne on March 10th and 11th for a "Spring Update".
Main topic was a new guideline for medical devices, for which the guideline were introduced discussed during the two days. It is expected that the new regulation will be released in June 2016.
TUEV Rheinland as “Notified Body according to § 15 Medical Devices Act” and conference host was able to feature interesting speakers from regulatory bodies as well as from the industry. From Systec & Services in Karlsruhe, Mr. Titus Krauss, Director Sales & Marketing, introduced a case study where a project was carried out in 2015 at a well-known medical device manufacturer in Western Switzerland. In this fully validated solution, which Systec & Services implemented, the entire vacuum drying process is controlled and monitored by the implemented MES solution. The process was remarkable improved, more concise information is now available, and the Device History Record is now generated automatically.
The attendees where very interested in the positive results achieved in this project. As the level of automation is rather low in the medical device industry as of today, the presented results have the potential for improvements with many of the present attendees.
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