ISO 13485

The company relies on a wealth of experience, coupled with on-going research in the field of nano-structured materials for Life Sciences applications, and has many facilities not only for materials development, processability and analysis, but also for their further certified manufacturing, including medical devices, according to ISO 13485 QMS (Quality Management System). Our company is certified with ISO 13485 QMS since 2016. All our equipment can be easily implemented in customers workflow and QMS and we can provide on-site IQ/OQ services and calibration of equipment and climate control unit.

ISO 13485 TUV logo

 

MANUFACTURING

Electrospun advanced wound dressing (Class IIb Sterile CE Marked Medical Device) 

 

NAD dressing

NAD dressing

 

Electrospun facemask with active ingredients for skincare (CE Marked cosmetic) 

Face mask cosmetic

Face mask cosmetic

Face mask cosmetic