Airon Corporation
Established in 1997, Airon Corporation is a privately held company focused on maximizing our patented oxygen-powered gas control technology. The inherent safety and long-term reliability of this technology make our ventilators and CPAP systems unique in today’s world of electronics. Any patient, anywhere is more than our corporate tagline – it is our prevailing goal. Any patient, anywhere is more than our corporate tagline – it is our prevailing goal. Every day Airon brings innovative pneumatic life support ventilation products to healthcare workers and patients worldwide.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About Us
Our products are designed to support injured or critically ill neonates, infants, pediatrics, children, and adults in a variety of clinical settings including EMS, hospital, ER, OR, ICU, MRI, and during transport.
In fact, Airon’s technology was licensed by GE Healthcare and manufactured by Ford for the 50,000 ventilators in 100 days response to Covid-19.
All of our products are proudly made in Melbourne, Florida, USA.
History
Airon responds with their new MACS stand-alone CPAP system. MACS CPAP to provide EMS with an easy-to-use, rugged, lightweight option.
Airon signs on with their first distributor for Asia and Indonesia
Airon exhibits at ArabHealth MONTH and gains rapid exposure in Middle East and Asian markets
Airon Corporation receives the 2011 Florida Companies to Watch award in recognition of the company’s growth and contribution to the Melbourne and Florida economies. During the three years prior to the award, Airon averaged a 70% annual increase in revenue, increased employment, added two new products, become ISO certified, and expanded internationally.
Reviews post accolades such as “will change the way you deliver pre-hospital care,” and “a little workhorse that delivers big performance.”
Airon attends the European Conference on Pediatric & Neonatal Mechanical Ventilation in Montreux Switzerland. Airon’s ongoing pledge is to provide high-quality, affordable critical care products to healthcare providers worldwide
Airon’s highly unique technology is licensed by GE Healthcare and manufactured by Ford to meet the national demand for ventilators. To help augment Ford’s production, Airon expands their Florida facility and doubles their production, all while continuing to meet their ongoing customer commitments.
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: