Paragonix Technologies, Inc., a commercial-stage medical device company marketing the Paragonix SherpaPak Cardiac Transport System, declared today 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 a globally acknowledged quality standard exact to the medical device industry. ISO 13485:2016 demonstrates Paragonix’s commitment to the highest level of medical device quality controls and to meeting client and international regulatory expectations. Certification mandatory Paragonix to undergo the BSI Audit before March 2019, to confirm uninterrupted product availability to a growing client base globally.
Adam Collette, Ph.D., VP Commercial Operations, for Paragonix commented,”We are very satisfied to have certified our QMS as compliant with ISO 13485:2016. Our team’s focus on creating a “quality-first” culture led to achievement of this milestone well ahead of schedule. ”
The Paragonix SherpaPak Organ Transport System product portfolio combines inventive cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organ to recipients for implantation. The Paragonix SherpaPak System consists of multiple components; 1) an outer transport shipper which temperature controlled elements, 2) 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, 3) a data logger that monitors the temperature of the organ during transport, and 4) a Bluetooth-connectivity to monitor, record and download preservation temperature and storage times to handheld devices.
Bill Edelman, Chairman & CEO, for Paragonix commented, “Our devoted team of safety and quality experts is a key pillar of Paragonix’s commitment to world-class, high-quality products. With the implementation of ISO13485:2016, Paragonix is fully aligned with worldwide regulatory needs. We are looking forward to supporting the transplant community with the Paragonix SherpaPak Cardiac Transport System in the US and in Europe.”