Medical Devives and ISO-Certification
Quality has always been our top priority. Long before ISO 9000 was invented in automobile manufacturing in the early 1990s, our company had a deep-rooted awareness of quality. When the then Medical Devices Directive 93/42/EEC became binding for medical device manufacturers in the mid-1990s, it was only a small effort for us to write our existing specifications into a QM manual and in accordance with the valid regulations of the then applicable ISO 9001 certification.
In 2003, our QM system was adapted to the new DIN EN ISO 13485 in order to continue to reliably meet the legal requirements of the European Directive 93/42/EEC.
Since September 26, 2023, our products have been approved and certified in accordance with the currently valid European Medical Devices Directive 2017/745 (MDR).