Quality management

Our mission is to advance scientific understanding and medicine by providing technologies for biomedical research and cellular therapy. Our top priority thereby is to ensure patient safety and satisfy our customers by providing products and services of the highest quality. 
Our management and employees are highly committed to this mission, which we diligently incorporate into our daily business. Our understanding of quality is based on: 

• the identification, implementation, measurement and continuous improvement of our processes needed to provide reliable products and services of the highest quality
• the optimal understanding and achievement of scientific and customer needs and conformance to regulatory requirements
• the optimal qualification and motivation of our employees and their commitment for continuing education
• the stipulation of stringent quality criteria for suppliers, partners, and contractors

For these reasons we maintain and continuously improve a certified quality management system in compliance with the international standards of:

• Regulation EU 2017/745 Medical Device Regulation (MDR), Directive 93/42 EWG,21 CFR 820, MDSAP, ISO 13485
• ISO 9001
• Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
• and other relevant applicable regulations, guidelines and standards.