International Regulatory Compliance Information

Quality Management System

ISO 13485: 2003

FDA

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations
Establishment Registration

Notified Body/Registrar/Certification Body

Restech maintains ISO 13485:2003 certification and is audited every year by

UL
Underwriters Laboratories
2600 N.W. Lake Rd.
Camas, WA 98607-8542
877.854.3577
www.ul.com

Product Certifications and Approvals

Australia
> ARTG Certificate

Canada
> Health Canada Medical Device License
> ISO 13485 Certificate
> Medical Device Listing

Europe
> UL International (UK) Ltd.

Taiwan
> TFDA Certificate

United States
> FDA Listing

Global Regulatory Representatives


Emergo

Europe – Emergo
The Hague, Netherlands
Phone: +31.70.345.8570
www.emergogroup.com/services/europe







© Respiratory Technology Corporation 800.352.1512 San Diego, CA ~ privacy policy and terms of use