Airon Successfully Completes ISO 13485:2016 / Medical Device Single Audit Program
January 20, 2019

In December 2018, Airon received certification for the successful completion of a Quality Management System audit under the new Medical Device Single Audit Program (MDSAP). This achievement demonstrates Airon’s ability to provide safe and effective medical devices that consistently meet the highest quality and safety standards for Airon’s pNeuton and MACS products in critical care and emergency medicine.

Multinational Quality and Safety Compliance

MDSAP consists of a scrupulous two stage audit methodology. Stage 1 is a documentation review and an evaluation of the readiness of the manufacturer to undergo the Stage 2 audit. The Stage 2 audit is to determine if all applicable Quality Management System (QMS) requirements of ISO 13485 and all other regulatory requirements from the participating regulatory authorities have been effectively implemented. Airon’s completion of both Stage 1 and Stage 2 documents Airon is in compliance with the standard and regulatory requirements of multiple regulatory jurisdictions including United States FDA, Health Canada, Japan and European International Standards.

An Ongoing Commitment to Healthcare Provider Confidence

“Healthcare providers in the hospital and emergency medical system can feel confident that Airon’s products will provide the performance and reliability needed to support the delivery of optimal patient care and safety,” stated Eric Gjerde, Airon’s President and CEO. “We started Airon over 25 years ago with a goal to advance the level of respiratory support and care, and provide better experiences and outcomes for patients worldwide. This MDSAP achievement is testimony that we remain on track with our goal, and relevant for today’s rigorous patient care requirements.”