Preventive detection of material and batch fluctuations? Continuous process monitoring with integrated user management? Archiving and forwarding of all quality data? Error-free production?
Quality assurance is essential in the medical sector. All components produced must be highly precise and guaranteed to be safe.
This is due to the vital relevance of the end products and the therefore highly regulated markets. In particular, the EU Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) set rules for the safety and effectiveness of medical and pharmaceutical products.