Airway Medix pomyślnie przechodzi pierwszy audyt nadzoru i utrzymuje certyfikat ISO 13485
Airway Medix przeszła pierwszy audyt nadzoru ISO 13485 bez żadnych niezgodności i utrzymuje certyfikat wydany przez CeCert. Certyfikowany system obejmuje projektowanie, produkcję i sprzedaż wyrobów medycznych spółki oraz wspiera jej działalność w UE, USA i na innych rynkach.
Pełna treść w języku angielskim (oryginał)
Warsaw, July 20, 2026: Airway Medix S.A., a MedTech company listed on the Warsaw Stock Exchange focused on clinical airway management solutions, announced that it has successfully passed its first surveillance audit of its Quality Management System under the PN-EN ISO 13485 standard, with a positive result and no nonconformities identified. As a result, the Company maintains the certificate issued by CeCert Sp. z o.o., an accredited certification body.
The certification covers Airway Medix's product design and development, manufacturing, and sales processes for its medical device portfolio. Maintaining ISO 13485 certification is a key requirement supporting the Company's ability to sell its medical devices across European, American, and other international markets.
ISO 13485, "Medical devices, Quality management systems, Requirements for regulatory purposes", is recognized internationally as the benchmark framework for meeting the comprehensive quality management requirements applicable to medical device manufacturers.
The maintained certification comes as Airway Medix continues to build on the transformation it completed: moving its R&D, production, and regulatory functions to Europe and shifting from a research-focused organization into a commercially driven business, with its first product reaching the market in early 2026. The Company continues to sell its products and is working to further internationalize its management structure as it grows its presence across European markets, the Gulf region, and the United States.
About Airway Medix S.A.: Airway Medix S.A. focuses on the research, development and commercialization of innovative disposable devices for mechanically ventilated patients in Intensive Care Units (ICUs), as well as life-threatening patients and anesthesiology departments. The products offered by Airway Medix address the most pressing clinical needs and fill a gap in current medical devices. Airway Medix S.A. has been listed on the Warsaw Stock Exchange since 2014.
Komunikaty prasowe publikowane są w formie wydanej przez Airway Medix S.A. Informacje o produktach są zgodne z instrukcjami używania.
