Quality/Regulatory Certificates

Quality Management System

The NP Medical Quality Management System is certified to ISO 13485:2016 and is fully compliant to 21CFR820, the US FDA Quality Systems Regulations.

ISO Certificate: Design, Development, and Manufacture of Fluid Control Components/Devices for Medical Markets

View of NP Medical Establishment registration on the FDA Website

Notified Body / Certification Body

NP Medical maintains ISO 13485:2016 certification by:

DEKRA Certification B.V. 

Utrechtseweg 310, 6812 AR Arnhem

P.O. Box 5185, 6802 ED Arnhem, The Netherlands

T + 31 88 96 83000

F + 31 88 96 83100

Global Regulatory Representatives

Emergo Europe, The Hague, Netherlands

T + 31.70.345.8570