Regulatory Information
Aspen’s Quality Management System maintains compliance to 21 CFR 820 and EU MDR (2017/745) per Product Classification Requirements.
US FDA (21 CR Part 820) complianceWe are fully compliant with the US FDA Quality System Regulation. View our Establishment Registration on the FDA website.
View 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
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
www.emergobyul.com
