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QUALITY SYSTEMS

Bio/Data Corporation's Quality Policy is to produce products and services that meet our customers' expectations for performance while providing a maximum level of customer satisfaction.

To affirm this commitment, Bio/Data Corporation has established a comprehensive quality assurance system which meets the requirements of the United States Food and Drug Administration's Quality System Regulation (commonly called the cGMP and detailed in Title 21 CFR Section 820) and complies with the ISO 13485:2016 quality standards.

Our products are manufactured to conform to the EU 98/79 EC Directive and the Canadian SOR/98282 Medical Device Regulations. These quality assurance regulations and programs permit for worldwide marketing of our products.

BIO/DATA CORPORATION'S QUALITY ASSURANCE SYSTEM CONCENTRATES ON PROVIDING:

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  • ​Defect-Free Products and Services to its Customers

  • On Time Delivery

  • Continual Improvement to all Products and Services Offered

HOW DOES BIO/DATA CORPORATION MEASURE ITS COMMITMENT TO QUALITY?

Bio/Data Corporation measures its commitment to quality through timely and periodic review of the data generated by its Quality Assurance System. These reviews generate Corrective and Preventative Actions (CAPA) that help to improve our products and services.
 
Bio/Data Corporation supports global efforts to standardize test performance and harmonized interpretive guidelines. With laboratories around the world relying on Bio/Data Corporation's aggregometers and reagents, lab professionals are able to provide accurate hemostasis monitoring by running platelet function and activation tests under the same conditions time after time. As a manufacturer and distributor of hematological medical laboratory products, our Company continuously works to improve its test systems.