SEKO Logistics has gained ISO 13485 quality management certification for its facility in Amsterdam, as it aims to strengthen its service offering for medical device manufacturers and distributors.
Spearheaded by numerous ISO 13485 facilities across the United States, SEKO’s MedTec business has grown 20% annually in each of the last five years and now represents 13% of the company’s global revenue. SEKO MedTec supports medical device manufacturers that have products ranging from large laboratory equipment to small homecare devices.
The scope of the ISO 13485 certification 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 fulfilment. In the Netherlands and at all of its other certified facilities, SEKO is now qualified to carry out technical services for customer products, such as surgical kitting, medical device re-working, device quality inspection, testing and decontamination.
SEKO’s logistics centre in Amsterdam’s Schiphol Logistics Park opened at the beginning of 2018 and is the company’s second largest operation in Europe. It will now be a major MedTec hub for SEKO on the continent and play a key role in managing any growing demand for the company’s international transportation and fulfilment 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, trade shows and events.
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. 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.”
Many of SEKO MecTec’s customers manufacture medical devices and technology equipment such as ultrasound, x-ray, mammography, anesthesia, ventilators, personal health and rehabilitation devices, incubators, surgical robots and hospital beds.
