Paragonix Technologies, Inc., a Braintree, Mass.-based, commercial-stage medical device company marketing the Paragonix SherpaPak Cardiac Transport System, announces that the company has received ISO 13485:2016 certification for its quality management system (QMS) following review by the British Standards Institute (BSI).
ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry. The certification demonstrates Paragonix’s commitment to the highest level of medical device quality controls and to meeting customer and international regulatory expectations. The ISO certification required Paragonix to undergo the BSI Audit before March 2019, to ensure uninterrupted product availability to a growing customer base internationally.
The Paragonix SherpaPak Organ Transport System product portfolio combines innovative cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organ to recipients for implantation. The system consists of multiple components, including an outer transport shipper which temperature controlled elements; a sterile, nesting organ canister set which provides a double, rigid barrier in which the organ is immersed and suspended in a cold storage fluid cleared for use in storing and transporting donor organs; a data logger that monitors the temperature of the organ during transport; and Bluetooth connectivity to monitor, record and download preservation temperature and storage times to handheld devices.
“Our dedicated team of safety and quality experts is a key pillar of Paragonix’s commitment to world-class, high-quality products,” says Bill Edelman, chairman and CEO, for Paragonix. “With the implementation of ISO13485:2016, Paragonix is fully aligned with global regulatory requirements. We are looking forward to supporting the transplant community with the Paragonix SherpaPak Cardiac Transport System in the U.S. and in Europe.”