AiroDoctor manufacturing facility certified
This time, it was not the AiroDoctorⓇ air purifier itself that was certified, but its manufacturing facility. This ISO 13485:2016 certification represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. As such, it also applies to all future product models based on UV-A photocatalysis.
"This is a milestone for the current AiroDoctor and other future products with photocatalysis technology. The certification opens up new markets and new opportunities for us as of now." - Carsten Hermann, co-developer of the AiroDoctor.
The ISO 13485:2016 certification is considered the foundation for advancing into the legally regulated area of medical devices.
What does this mean for AiroDoctor?
- ISO 13485:2016 has far-reaching significance for the innovative air purifier technology with UV-A photocatalysis.
- The entire existing and future AiroDoctor product line is produced according to this standard.
- ISO 13485:2016 certification facilitates AiroDoctor's access to various healthcare facilities with immediate effect.