ISO 13485 and CE Marks

Neurovision Medical Products’ quality management system is ISO 13485 certified by TUV USA. ISO 13485 is an International Organization for Standardization (ISO) standard, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

The annual inspection audits confirm maintenance of our quality management system to ISO 13485.

2021 TUV Certificate(s) – ISO 13485:2016

DIN EN ISO/ EN ISO 13485 2016

ISO 13485:2016 under MDSAP

Neurovision Medical Products’ Cobra 3-Plate EMG tube and Nerveäna+ nerve monitoring system are additionally certified by TUV for the European market. The CE mark signifies that these products conform to EU performance, health, and safety standards and meet the requirements of the directive.

2021 TUV Certificate – CE 0044

EC-Certificate acc. 93/42/EEC Annex II without (4)


For more information about certification and auditing please reference:

TÜV USA EN ISO 13485 certification

TÜV NORD MDSAP

TÜV NORD CE Marking

ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes