SEKO Logistics’ European and U.S. MedTec Operations Awarded ISO 13485 Certification
SEKO Logistics’ European MedTec control tower has been awarded ISO 13485 certification, the foundation for manufacturers to address medical device directives, regulations, and responsibilities.
SEKO MedTec is one of SEKO Logistics’ biggest and fastest-growing businesses and provides highly specialized solutions focused exclusively on the medical device industry. This includes dedicated program management for demonstration equipment, finished goods and returns, as well as contract logistics and fulfillment services. SEKO’s engineering, transportation and software services for the industry are backed up by control towers, knowledgeable staff, and dedicated clean rooms and facilities.
In the U.S., SEKO has also achieved ISO 13485 certification at its U.S. MedTec control tower located in State College, Pennsylvania, as well as for its MedTec warehouses and hubs in Costa Mesa, California, Pittsburgh, and Baltimore.
“Quality and compliance underpins everything that happens in the medical device sector and this certification is an extension of SEKO Logistics’ specialization in this important and strictly-regulated industry,” said Robert Shearer, managing director of SEKO MedTec. “We continue to innovate with sophisticated integrated logistics solutions and software for the medical industry. Gaining ISO 13485 certification for our EU MedTec operation, coupled with full certification of all of our U.S. MedTec sites, provides our current and potential clients with the knowledge that their products are handled to the highest standards across both continents.”
ISO 13485 is the quality standard in the medical device industry and is adopted by authorities, suppliers, and manufacturers around the world to demonstrate their commitment to protecting the safety and integrity of medical devices.