MEAN WELL acquired EN ISO-13485: 2012 Medical Devices- Quality Management System
MEAN WELL ENTERPRISES CO., LTD acquired the European Standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems, under the evaluation and auditing by TUV Rheinland in May of 2017.
According to the requirements of the European Union, medical products entered into the European market must have CE mark, and EN ISO-13485 provides medical device manufacturers to establish a quality management system to comply with its CE Declaration of Conformity. MEAN WELL acquired ISO-13485 certification will accelerate its medical power supplies to get into the global markets, in particular to the countries requiring manufacturers to comply with ISO-13485 certification, such as the European market, the United States and Canada and others.
Along with the ongoing global wide aging society, the development of home care market and medical biotech industry has highly flourished. MEAN WELL invested large numbers of resources into medical power supplies, till now, it has reached more than 70 series and over 400 models which cover 5W~600W output wattage and are separated into internal PCB type, on board type, enclosed type and external adaptors by appearance, installations and applications.
The design of MEAN WELL medical power supplies all comply with the up-to-date IEC60601-1 3rd edition, possessing MOPP or 2xMOPP level and most of the models are suitable for type BF (Body Floating, patient contact) medical devices, ultra-low leakage current (<50uA for lowest), supplying Class I (with F.G) and Class II (without F.G) types, low no load power consumption and models with various output voltages are available to choose.
For more details of medical products, please refer to Medical Catalog, or visit MEAN WELL website: www.meanwell.com.