Regulatory Compliance Information

FDA

Device Listing/Establishment Registration

US FDA Good Manufacturing Practice (GMP)
Restech is compliant with 21 CFR Part 820, US FDA Quality Systems Regulations


Notified Body

Restech maintains ISO 13485:2003 certification
and is audited by Underwriters Laboratories
2600 N.W. Lake Rd.
Camas, WA 98607-8542
877.854.3577
www.ul.com
UL


Quality Management System

ISO 13485: 2003

European Authorized Representatives

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
(+49)-511-6262 8630
www.mdss.com 


Product Certifications and Approvals

Europe Canada