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Our Quality

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.

Quality Management System

Airon quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. QMS is expressed as the organizational policies, procedures, processes and resources needed to implement quality management.

Quality Management System Certification

ISO 13485 Quality System Certification

Medical Device Single Audit Program (MDSAP)

Airon participated in the MDSAP regulatory audit of our medical device facility and quality management system; the MDSAP certificate indicates that Airon complies with the regulatory requirements for the markets defined in the certificate.
Airon markets include – United States FDA, Health Canada and European Union.
MDSAP 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 13485:2016 certification and is audited every year by:

Intertek Systems Certification
70 Codman Hill Rd
Boxborough, MA 01719
Telephone: +1 (978) 263-2662
www.intertek.com

Regulatory Compliance

International Regulatory Compliance Information

Under regulatory compliance, our goal is to take steps to comply with relevant laws, policies, and regulations for medical device manufacturing and marketing Airon products. All Airon products are designed, manufactured, and supported based upon sound quality procedures. Every device is CE marked as well as USA FDA cleared.

Product Certification 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

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

Global Regulatory Representative

Europe – Authorized Representative

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