Adding medical device standards strengthens quality system for all product lines
Toms River, NJ (January 24, 2013) – Leading gas conditioning products manufacturer Perma Pure has recently expanded its ISO certification status, achieving ISO 13485:2003 certification pertaining to the manufacture of medical devices, in addition to its current ISO 9001:2008 status.
The company’s quality management system was recently audited by its registrar, BSI and found to be in compliance with the provisions of the ISO 13485:2003 standards. ISO 13485:2003 certification ensures that a company supplying medical devices has met a specific set of standards demonstrating its ability to provide medical devices that consistently meet customer and regulatory requirements. Perma Pure’s ME Series products are used to dry breath streams prior to analysis and also to humidify medical gases, increasing patient comfort.
“The methodology and mindset necessary to achieve and maintain the ISO 13485 certification has a positive influence on the design, manufacture, and sale of all of our products,” explains Perma Pure President Richard Curran. “We are a better company for having achieved this certification and customers of all of our products will benefit from our improved ability to respond to their requirements.”
Perma Pure’s ME Series dryers remove only water vapor from the patient’s breath stream without affecting the levels of CO2 or anesthetic agent in the sample. This enables rapid and precise analysis, which in turn allows the medical staff to better monitor the patient’s condition. Perma Pure is the only ISO 13485 registered company that offers Nafion™-based breath dryers to the medical device market. It has been an ISO 9001 registered company since 2005 and is registered with the US FDA as a Class 2 Medical Device manufacturer.