SEKO Logistics has significantly augmented its healthcare logistics services in Europe by gaining ISO 13485 quality management certification for its major facility in Amsterdam, strengthening its robust service offering for medical device manufacturers and distributors – especially those with critical quality and compliance requirements.

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 already supports seven of the world’s top ten medical device manufacturers, with products ranging from large laboratory equipment to small home care devices. Combining these new capabilities in Amsterdam with SEKO’s expertise in White Glove deliveries will enable it to earn an even bigger share of the global medical device market, which is expected to increase in value to more than $400 billion by 2023.

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. 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, med device re-working, device quality inspection, testing and decontamination.

This successful audit follows six months of preparation and training by SEKO’s MedTec quality management team, who were also able to leverage the knowledge gained from the ISO 13485 certifications of SEKO’s operations in Baltimore, Pittsburgh, State College, PA and Costa Mesa, CA. SEKO is also working towards gaining the ISO quality standard at three additional locations in the US.

SEKO’s 80,000 sq. ft. logistics center 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 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.
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 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 added value provided by SEKO’s ISO 13485 accreditation will accelerate its growth in medical logistics and is complemented by SEKO Logistics’ award-winning high value shipping services and digital logistics solutions, which give customers real-time control and visibility of their inventories and supply chains.

SEKO’s MedTec solutions at a glance:
• A full suite of customizable, best-in-class logistics and 3PL services for sensitive, high-value products, specializing in medical devices and technology
• North American and intra-Europe White Glove transport services
• Demo management – inventory optimization services
• Finished goods installations
• Removal & returns management
• First & last mile, time-definite White Glove services
• Custom crating & packaging - evaluation, design, production
• In-house developed real-time transportation and asset management IT systems
• Strategically-located Control Towers and Distribution Centers
• Dedicated Account Logistics Coordinators, Program Managers, and Inventory Control teams
• Integration of process engineering, compliance and logistics operations
• FDA registered, C-TPAT certified facilities with scalability
• AEO certified operations in Denmark, the Netherlands and United Kingdom
• Full Quality Management System to support ISO 9001:2015 and ISO 13485:2016