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2021.02.26Press Release

MOL Logistics (Netherlands) Acquires ISO13485 Certification for Medical Device Quality Management Systems

February 26, 2021

 

TOKYO-MOL Logistics Co., Ltd. (MLG; President: Shuhei Togo) today announced that in January, its subsidiary in the Netherlands, MOL Logistics (Netherlands) B.V. obtained certification under ISO13485, the international standard for establishment of medical device quality management systems.

ISO13485 applies to all parties involved in medical device supply chains. Acquisition of this certification proves that the parties meet the strict requirements of EU Medical Device Regulations (MDR). It also proves that the certified parties meet the most stringent requirements related to supply chains in the medical device industry.

EU regulations regarding MDR for import and trade of medical devices are becoming stricter, with the goal of improving the overall quality of medical goods in the EU. And when it comes to logistics related to medical devices, demand for partners that can offer high-quality service is also growing.

MOL Logistics (Netherlands) has already successfully operating in line with a number of requirements from ISO 13485, including carrier management using qualified healthcare transport companies with temperature-controlled possibilities, monitoring temperature/humidity in dedicated healthcare spaces in warehouses, labeling, medical device testing, and so on. This motivated the company to pursue official certification.

The MOL Logistics Group, including MOL Logistics (Netherlands), is unified in working toward further expansion of medical device and healthcare-related cargo trade.