Research Triangle Park, North Carolina, December 5, 2013 — Marken announced today that their 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 2-day audit to verify that the Clinical Supply Center 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 Clinical Supply Center is strategically located to provide regional distribution of pharmaceutical products and medical devices for the clinical trials industry.
Gerit Offenhauser, Senior Vice President, Clinical Trials Distribution, commented, “ISO 13485 is an extra step that Marken undertook to demonstrate our commitment to our 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.”