Regulatory Information
Quality Management System
Aspen’s Quality Management System maintains compliance to 21 CFR 820 and EU MDR (2017/745) per Product Classification Requirements.
View our Establishment Registration on the FDA websiteView our Actor Registration (SRN) on EUDAMED
Registrar
Aspen Medical Products maintains ISO 13485 certification and is audited every year by:
NSF-ISR
789 N Dixboro Road
Ann Arbor, MI 48105 USA
Telephone: +1-734-827-6800
Website: www.nsf-isr.org
ISO 13485:2016 quality system certification
European Authorized Representative
Emergo Europe
Westervoortsedijk 60
6827 AT, Arnhem
The Netherlands
Telephone: +31-70-345-8570
Website: www.emergobyul.com
