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Monday, 01/09/2023 11:28:21 AM

Monday, January 09, 2023 11:28:21 AM

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Shina Systems: For Informational Purposes Only

Shina Systems ensures product quality and regulatory compliance. Our quality records compliance is regularly audited by MEDCERT a registrar EU Notify-body to certify our compliance to ISO 13485:2016, Medical Device Directive 93/42/EEC as amended by 2007/47/EC, ISO 14971:2012, and IS/EN 62304 Medical Device Software life Cycle processes. Shina Systems also holds 510K to its 3Di product to guarantee that they follow FDA regulations.


https://www.shinasystems.com/resources/
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