The quality of our products is for us a task and an obligation towards our customers of utmost priority. As early as in the 90s, Hermann Medizintechnik was a pioneer in terms of quality management.
This standard has been maintained until today and we not only want to comply with it in future as well but are constantly trying to improve and advance it.
Our company has a documented quality management system and, from Development over Production up to Sales, is consistently certified in accordance with DIN EN ISO 13485:2012.
This quality management system complies with the requirements laid down in Annex II of Directive 93/42/EEC on medical devices and is also in line with the requirements of rules and regulations of many countries all over the world.
Looking back on many years of experience with regulatory affairs, we will be glad to support you during any pending registration procedures.
This solid basis allows us to document the products we develop and manufacture in accordance with the required standards and issue the corresponding certificates of conformity.