Marken's Singapore biological kit-building facility has been certified to ISO 13485 standards for the storage and distribution of medical devices. This certification validates a quality management system for medical device kits, both sterile and non-sterile, at the Singapore facility.
Marken received the certification after a two-day audit to verify that the depot meets ISO requirements for consistent quality, control process performance, and effective documentation systems. Marken also has 9001 certification in Singapore, which includes requirements for continual improvement and customer satisfaction.
Gerit Offenhauser, senior vice president, Clinical Trials Distribution, said, "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."