Quality Assurance Services

Development of quality management systems
Implementation of QM systems for ISO 9001, ISO 13485:2003
Preparation of streamlined quality manuals and quality documents
Development of incident reporting system
Accomplishment of internal quality audits
Cooperation with Notified Bodies
Training and seminars
MDD and CE-certification of medical devices and IVD
Manufacturing and product hygiene


We can provide our Quality Assurance Services in the US through our cooperation partners.