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 cleared.

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification
ISO 9001 quality system certification

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
pNeuton ventilator license | MACS license | patient circuit license
miniFlow license | miniFlow nasal mask license | miniFlow nasal prong license

EUROPE – CE Marking certificates
Airon EC Certificate

EUROPE – Declarations of Conformity

UNITED STATES – FDA 510(k) cleared
pNeuton A | pNeuton S | MACS | pNeuton mini

GLOBAL REGULATORY REPRESENTATIVES

EUROPE – Authorized Representative

Emergo Europe
Prinsessegracht 20
2514 AP, The Hague, Netherlands
Telephone: +31.70.345.8570