The certification encompasses key areas of the company’s operations, including product design and
development, manufacturing, and sales of medical devices. Achieving ISO 13485 certification is a major
step in ensuring compliance with regulatory requirements in key markets and reinforces the company’s
commitment to maintaining the highest standards of quality across all aspects of its business.
ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes –
is internationally recognized as the leading standard for quality management systems in the medical
device industry.
“Successfully completing this certification process is a testament to the strength of our team and the
maturity of our quality systems,” said Anna Aranowska-Bablok, CEO of Airway Medix S.A. “Our partners
have been waiting for this certification, and now it’s time to move forward with market implementations.”