RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Yukon Medical, LLC., a leading developer of innovative pharmaceutical preparation and delivery devices announced today that it has received ISO 13485 certification for its quality management system.
ISO 13485 is an internationally recognized standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet customer and regulatory requirements for the design, development and manufacture of medical devices. Yukon Medical has also obtained a certificate for CE Marking its ViaLok™ Vented Vial Access Devices.
“Achieving ISO 13485 certification is a major milestone for Yukon Medical. We have had a GMP compliant system in place for some time but it is a significant achievement to have an ISO 13485 compliance certification from a third party registrar to continue to demonstrate our continuing commitment to excellence,” said CEO Todd Korogi.
About Yukon Medical, LLC.
Yukon Medical designs state-of-the-art products that simplify drug reconstitution, increase caregiver safety and address complex challenges using novel approaches. Yukon also possesses extensive experience in designing and implementing innovative pharmaceutical devices through customization services to optimize products that meet customers’ specific needs.
Yukon Medical, LLC.