As a quality-oriented system supplier, we regularly check our three factories and services for compliance with the requirements and guidelines of the strict quality and standard requirements.
We have been using the quality management systems according to DIN EN ISO 9001 and 13485 for many years. We are also certified according to ISO 50001 as the continuous improvement of energy-related services with constant optimization of the energy efficiency and cost effectiveness is important to us. We continue to take account of the requirements for GMP-compliant design (Good Manufacturing Practice). Our clean rooms meet the requirements according to DIN EN ISO 14644-1 ISO Class 7 and are continuously monitored. We also take account of other elements from the regulations and standards 21 CFR 820 Quality System Relations (Medical Devices), ISO 14001, ISO 15378 and ISO/TS 16949.