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ISO 13485 Certification

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The manufacturing and distribution facility at our headquarters is fully certified to ISO 13485 , a comprehensive standard of quality management systems, specifically for Medical Device Manufacturers.

By earning this internationally recognized certification, we offer our customers and suppliers an additional level of confidence in our quality, reliability, and commitment to continuous improvement.  Hardy Diagnostics’ ISO 13485 certification indicates that the highest standards are guaranteed, because we know that you depend on the quality of our products and services.

Jay Hardy

Jay Hardy
President