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
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
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
Europe – CE Marking certificates – Airon EC Certificate
Europe – Declarations of Conformity
Global Regulatory Representative
Europe – Authorized Representative
2514 AP, The Hague, Netherlands