---
title: certifications
description: "machineMD has obtained “ISO13485: 2021”, an international regulatory requirement for medical devices from TÜV Italia."
---

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    - [Multiple Sclerosis](https://www.machinemd.com/multiple-sclerosis)
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    - [Parkinson's Disease](https://www.machinemd.com/parkinsons-disease)
    - [Progressive Supranuclear Palsy](https://www.machinemd.com/progressive-supranuclear-palsy)
    - [Alzheimer's Disease](https://www.machinemd.com/alzheimers-disease)
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    - [NAION](https://www.machinemd.com/naion)
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    - [NAION](https://www.machinemd.com/naion)
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## Certifications

###### 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.

![QMS Zertifikat](https://www.machinemd.com/hubfs/QMS%20Zertifikat.png "QMS Zertifikat")

---

###### DEVICE CERTIFICATIONS

## CE Mark

ne**o**s™, 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).

![CE 2443 black](https://www.machinemd.com/hs-fs/hubfs/CE%202443%20black.png?width=306&height=150&name=CE%202443%20black.png "CE 2443 black")

[Download the Certificate](https://www.machinemd.com/hubfs/machineMD-certificate_ed1c2441-20241007130020_signed-2.pdf?hsLang=en)

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