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.
Medical technology innovations: Cutting Back on Melanoma Biopsies. With the most deadly form of skin cancer, melanoma, a huge number of dangerous-looking moles are actually harmless, but has always been impossible to know for sure without an invasive surgical biopsy. Today dermatologists have new help in making the right call — a handheld tool approved by the FDA for multispectral analysis of tissue morphology. The MelaFind optical scanner is not for definitive diagnosis but rather to provide additional information a doctor can use in determining whether or not to order a biopsy. The goal is to reduce the number of patients left with unnecessary biopsy scars, with the added benefit of eliminating the cost of unnecessary procedures. The MelaFind technology (MELA Sciences, Irvington, NY) uses missile navigation technologies originally paid for the Department of Defense to optically scan the surface of a suspicious lesion at 10 electromagnetic wavelengths. The collected signals are processed using heavy-duty algorithms and matched against a registry of 10,000 digital images of melanoma and skin disease.
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.
Real-time diagnostics. The intelligent surgical knife (iKnife) was developed by Zoltan Takats of Imperial College London and works by using an old technology where an electrical current heats tissue to make incisions with minimal blood loss. With the iKnife, the vaporized smoke is analyzed by a mass spectrometer to detect the chemicals in the biological sample. This means it can identify whether the tissue is malignant real-time. Surgeons will love this surgical Jedi knife which can significantly reduce the length of operations.