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Quality & Regulation
Shina Quality Statement
It is Shina Systems Ltd.’s policy to provide safe and effective imaging diagnostic software, PACS and imaging management software, committing to complying with quality, regulatory, and legal requirements. Shina strives to deliver best-in-class, high-quality products to exceed customer expectations and is dedicated to improving customer satisfaction by continually improving the company’s products and internal processes.
Shina Quality & Regulatory Compliance
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.