SEKO Logistics has gained the ISO 13485 quality management certification for its facility in Amsterdam, which will now be a major MedTec hub for SEKO in Europe. The certification will play a key role in managing growing demand for the company’s international transportation and fulfillment solutions, cross-border eCommerce, Omni-Channel, White Glove and Final Mile services. SEKO invested in this bigger location in the Netherlands to meet demand from its core industry verticals; aerospace, automotive, energy, government, industrial, medical, retail, technology, and tradeshows and events.
The scope of the ISO 13485 certification – following an audit by bsi, one of the world’s leading business standards companies – qualifies SEKO to provide light contract manufacturing services, including assembly and inspection of medical devices, non-sterile product kitting and third-party logistics support, including inventory control, warehousing and order fulfillment.
Robert Shearer, managing director of SEKO MedTec, said: “ISO 13485 is the quality standard that meets the regulatory requirements of the medical device industry, so it is a valuable qualification for us as a logistics service provider and will differentiate SEKO’s offering in this fast-growing market. The Netherlands remains the premier 3PL and distribution location in Europe, and this latest investment in our service quality and clean room capabilities reflects our dedication and commitment to this market.”
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Many of SEKO MedTec’s customers manufacture high-value medical devices and technology equipment such as ultrasound, x-ray, mammography, anesthesia, ventilators, personal health and rehabilitation devices, incubators, surgical robots and hospital beds.
“The ISO Standard confirms that SEKO MedTec has the same high-level Quality Management System as our medical device manufacturer clients. This is especially important in the Netherlands because many of our biggest MedTec clients use it as the center of their European distribution programs due to the VAT deferral opportunities and the significant cashflow benefits this delivers,” added Shearer.
SEKO’s 80,000 sq. ft. logistics centre in Amsterdam’s Schiphol Logistics Park opened at the beginning of 2018 and is the company’s second largest operation in Europe.
