EN ISO 13485 Certification Expansion

hemotune AG has successfully expanded its EN ISO 13485:2016 certification to cover both sterile and non-sterile medical devices and nanoparticles for blood purification. This certification underscores our commitment to maintaining the highest standards of quality and safety in medical technology.

EN ISO 13485:2016 is the internationally recognized standard for medical device quality management systems. Achieving this certification for sterile and non-sterile nanoparticles reflects our dedication to rigorous regulatory compliance and continuous improvement.

At hemotune AG, we focus on advancing blood purification technologies to address critical illnesses and improve patient outcomes. This milestone strengthens our ability to bring innovative, high-quality solutions to the healthcare industry.

For more information about our technology and ongoing developments, stay connected with us.