We put our customers first. By offering user-friendly immunological assays, proficient technical service, and efficient delivery, we aim to always be of service.
We listen carefully to the needs of our customers and respond accordingly in order to build mutually fruitful relations. The aim to satisfy customer needs involves everyone at Mabtech and affects all customer communication. We are proud of continuously receiving numerous positive feedbacks and many returning customers.
Mabtech AB has chosen to comply with the international standards ISO 9001 and ISO 13485, for the establishment, maintenance and development of its quality management system. The compliance is audited annually by external audits and the certificates have been maintained without interruption since 2006 when Mabtech AB first aimed for certification.
The EU and the US (FDA) have established guidelines for the life sciences industry, known as Annex 11 and CFR21 part 11, respectively. These guidelines outline the use of computerized systems in clinical investigations and specify that the quality of source data obtained through these systems must match that of traditional paper records.
To ensure compliance with applicable guidelines, our software has been specifically designed to meet requirements such as history files, performance qualification, limited access, and time-stamped audit trails.
In addition to the basic criteria of international guidelines, we have added extra layers of control: