QUALITY MANAGEMENT

UNI CEI EN ISO 13485:2021

machineMD AG's Quality Management System is certified to comply with the requirements of ISO 13485: 2021, an international standard for medical devices, by TÜV SÜD (Italy).

The scope of application includes the design and development, manufacturing, and placing on the market of active non implantable devices in the field of neurology and ophthalmology monitoring and diagnosis. 

Through the certification and maintenance of the Quality Management System, machineMD strives to deliver safe and performant high quality precision devices.

DEVICE CERTIFICATIONS

CE Mark

neos^™, is certified as a Class IIa medical device under the European Union Medical Device Regulation (EU-2017/745 MDR) by TÜV SÜD Danmark (NB 2443).