Marken Singapore announced that its Singapore biological kit-building facility has now been certified to International Standards Organization (ISO) 13485 standards for the storage and distribution of medical devices.
This certification validates that Marken provides a quality management system for medical device kits, both sterile and non-sterile, built within the Singapore biological kit-building facility.
Marken was awarded the certification after an intensive two-day audit to verify that the depot meets ISO requirements for consistent quality, control process performance, and effective documentation systems.
ISO 13485 is in addition to Marken’s existing 9001 certification in Singapore, which includes requirements for continual improvement and customer satisfaction. Marken’s Singapore depot is strategically located to provide regional distribution of pharmaceutical products and medical devices for the clinical trials industry.
Marken clinical trials distribution senior vice president Gerit Offenhauser noted ISO 13485 is an extra step that the company undertook to demonstrate its commitment to its clients.
"This certification builds transparency for our Singapore biological kit production. Our clients can have complete confidence that our facility both meets and exceeds their expectations for Marken kit-building, storage and handling, and our organization as a whole. We continuously seek opportunities to deliver above and beyond traditional standards," Offenhauser added.