Regulatory Compliance

Airon Corporation is dedicated to the development, manufacture, and distribution of safe and effective medical devices designed for critical patient care.  We continuously review our products, process, and customer comments to ensure our products and services meet the highest level of expectations.  Our operations and products comply with all local, national, and international regulations. 

International Regulatory Compliance Information

All Airon products are designed, manufactured, and supported based upon sound quality procedures. Every device is CE marked as well as USA FDA approved.

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification (PDF format)
ISO 9001 quality system certification (PDF format)

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
View our Establishment Registration on the FDA website

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

Airon Corporation maintains ISO 13485:2003 certification and ISO 9001:2008 certification and is audited every year by:

Intertek Systems Certification
70 Codman Hill Rd
Boxborough, MA 01719
Telephone: +1. (978) 929-2100
www.intertek.com

PRODUCT CERTIFICATIONS AND APPROVALS

USA – FDA Free Sale Certificate – Certificate to Foreign Government

CANADA – Medical Device Licenses
Canada pNeuton license | Canada MACS license | Canada circuit license

EUROPE – CE Marking certificates (PDF format)
Airon EC Certificate

EUROPE – Declarations of Conformity (PDF format)

UNITED STATES – FDA 510(k) cleared/PMA approved devices
pNeuton A approval | pNeuton S approval | MACS approval

GLOBAL REGULATORY REPRESENTATIVES

EUROPE – Authorized Representative

Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570