Legal & Regulatory

Regulatory

Regulatory

Regulatory

Nova Medical subscribes to the following international regulatory authorities.

Quality Management System

Notified Body/Registrar/Certification Body

Nova Medical Inc. maintains EN ISO 13485 & ISO 13485 MDSAP and is audited every year by:

TUV Rheinland LGA Products GmbH
Tillystrasse 2, D-90431 Nuremberg
Germany

Product Certifications and Approvals

Canada –
- 3T 32 Channel Head Coil Medical Device Licenses
- 1TX32RX Head Coil 7T Clinic Medical Device Licenses
Europe –
- CE Marking Certificates

Global Regulatory Representatives

Australia – Sponsor
EMERGO AUSTRALIA – Sydney, Australia
Telephone: +61.2.9006.1662

Europe - Authorized Representative
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands

Nova Medical Proloader