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| ISO 13485 | ISO 9001 | ISO 14001 | QMS2173 | QMS5355 | ||
Manufacturing
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ISO 13485 Development, Production and Distribution of LCD Monitors, Peripherals and Computing System Solutions for displaying medical images and clinical parameters. |
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TAIWAN FDA QMS P2020, P2050 Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Picture Archiving and Communication System. 1.Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Medical Image Communication Device 2.Manufacture, Packaging, Labeling, Final Inspection and Release of Medical Image Storage Device |
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ISO 9001 The design, manufacturing and distribution of LCD monitor displays, peripherals, computing system and solutions. |
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ISO 14001 Design and Manufacture for LCD Display Monitor. |
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Safety & EMC Certification
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CB(IEC 60601-1) |
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CB(IEC 62368-1) |
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CE(EN 60601-1;EN 60601-1-2) | |
CE(EN 62368-1,EN 55032/EN 55035) |
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ANSI/AAMI ES60601-1, | |
UL 62368-1, CAN/CSA C22.2 No. 62368-1 |
| CAN/CSA C22.2 No. 60601-1 | |
FCC CFR Part 15 Subpart B, ICES-003 | |
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Others: CCC, VCCI, BSMI, etc. |
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| Environmental |  |
Others | |
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RoHS, REACH, WEEE |
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FDA, EU MDR |
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