Every member of our staff is aware of how important quality is and every one of them contributes to meeting the growing demands on quality. Extensive training and work-
shops ensure that each individual and the skills they possess are incorporated into all
the processes. Internal system, product and customer audits help us continuously
develop our understanding of quality, and document the rigorous adherence to and
optimization of all specifications.

Validations and qualifications during the industrialization phase constitute funda-
mental components within the creation of processes and equipment in compliance
with GMP. Our quality management system is certified according to ISO 9001,
ISO 13485 as well as Primary packaging standard DIN EN ISO 15378. It meets the
requirements of the Medical Device Council Directive 93/42/EWG, appendix II, as
well as cGMP- requirements of the FDA.