We meet the highest demands on the reliability of our processes.
Our services make an important and decisive contribution to the safety of patients treated with our packaged, sterilised or tested products. Against this background, we are subject to high demands on the reliability of our processes.
Our company has therefore committed itself to establishing and maintaining a comprehensive quality management system. It is based on the pharmaceutical GMP guidelines and the German drug law manufacturing approval, as well as on the FDA requirements, ISO 13845 (QM system for medical devices), ISO 9001 and ISO 17025 (competence of testing laboratories). Additionally we have a GLP certificate for cytotoxicity tests.
Due to these diverse sets of regulations, we are subject to several audits and inspections by notified bodies, accreditation and certification bodies, domestic and foreign supervisory authorities (e.g. FDA) each year. In addition, there are a large number of annual customer audits.
If, despite our extensive certifications and accreditations, you would like to (continue to) carry out your own QM audits with us, we would be pleased to welcome you.
However, please understand that we cannot offer this service free of charge or indefinitely. A timely agreement on deadlines and costs is indispensable for us to be able to cope with the considerable effort involved in addition to our work.
Your contact persons
If you have question concerning quality, please contact us: