Pneumeric Inc. has been successfully certified to ISO 13485:2016 (Quality Management System) by Perry Johnson Registrars, Inc.
ROCHESTER, Minn., April 2, 2025 /PRNewswire-PRWeb/ -- Pneumeric, Inc. is proud to announce that its Quality Management System (QMS) for medical devices has been certified for compliance to ISO 13485:2016 following extensive audit by qualifying body, Perry Johnson Registrars, Inc.
In receiving this certification, Pneumeric has demonstrated the effectiveness of its QMS and the underlying systems, procedures, and records in line with state-of-the-art industry expectations for quality management.
"This achievement of ISO 13485 certification is an important milestone in our pursuit to make our life-saving device, Capnospot®, available to a larger audience worldwide," says John Aho, MD, Ph.D. and CEO of Pneumeric Inc. "Perry Johnson Registrars worked closely with our team to make the process smooth and timely."
Pneumeric manufactures the small, lightweight and portable Capnospot® Pneumothorax Decompression Indicator that is designed to affix on the distal end of any commercially available needle angiocatheter or thoracostomy with a standard luer lock fitting used for decompression. As pneumothorax gas flows through the needle and Capnospot® device, the dark blue colorimetric paper turns bright yellow in seconds as it comes in contact with CO2.
The Capnospot® Tension Pneumothorax Decompression Indicator is available for purchase by medical professionals throughout the United States and in numerous countries worldwide through a large network of distributors. This certification opens additional opportunities for Pneumeric to collaborate with strategic business partners in new markets.
About Capnospot®
Capnospot® is an innovative medical device designed to enhance the accuracy and effectiveness of tension pneumothorax decompression procedures. By providing real-time, visual confirmation of successful decompression, Capnospot® improves patient care and supports first responders in making critical, life-saving decisions.
About Pneumeric, Inc.
Pneumeric, Inc. was founded in 2021 through a passion to elevate the standard for tension pneumothorax care and to reduce treatment failure and death. In 2023, the company received FDA clearance with a superiority claim and currently has two patents on the innovative Capnospot® device. Additional information about the product and company can be found at www.pneumeric-medical.com. Follow Pneumeric on LinkedIn at https://www.linkedin.com/company/pneumeric.
Media Contact
Todd Wiltshire, Pneumeric Inc., 1 617-922-7255, [email protected], www.pneumeric-medical.com
SOURCE Pneumeric Inc.
Share this article