MARCH 2022 – One of the first strategic goals for IC Biomedical was to build a world class biomedical cold storage business and to manufacture our products in a medical device compliant facility. The key step to achieving global medical device compliance was the development and certification of an ISO 13485:2016 Quality Management System (QMS). An ISO 13485:2016 QMS is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. Additionally, the required processes ensure medical devices and related services consistently meet customer and applicable global regulatory requirements.
IC Biomedical is proud to announce ISO 13485:2016 certification was achieved in March 2022, less than a year after the Cartersville GA manufacturing facility was opened. This certification is a key step in obtaining global medical device approvals and registrations for all IC Biomedical products.