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Bio/Data Aggregation Regulatory Systems


Bio/Data Corporation's Unwavering Commitment to Quality Assurance and Global Customer Satisfaction

Bio/Data Corporation stands resolutely committed to the unwavering pursuit of excellence in the production of products and services. Our dedication goes beyond the mere fulfillment of performance expectations; we aspire to surpass these benchmarks, aiming to achieve the highest levels of customer satisfaction.

This steadfast commitment finds tangible expression in the meticulous establishment of a comprehensive quality assurance system at Bio/Data Corporation. Our system is intricately designed to not only meet but surpass the stringent requirements outlined by the United States Food and Drug Administration's Quality System Regulation, recognized as GMP and meticulously detailed in Title 21 CFR Section 820. Our stringent quality assurance practices harmonize seamlessly with the exacting standards set by ISO 13485.
Furthermore, our commitment extends to the global stage, with our manufacturing processes meticulously aligned with the EU 2017/746 Directive IVDR. This ensures that our products not only meet but also surpass regulatory standards, underscoring our dedication to quality. The implementation of these robust quality assurance regulations and programs not only attests to our commitment to excellence but also serves as the cornerstone for the global marketing of our products, enabling us to reach and serve customers on a worldwide scale.


Quality Assurance
  • Delivery of flawless products and services to customers, free from defects.

  • Timely delivery of products and services.

  • Ongoing enhancement of all offered products and services


Bio/Data Corporation gauges its commitment to quality through regular and timely reviews of the data generated by its robust Quality Assurance System. These reviews lead to the identification of Corrective Actions and Preventive Actions (CAPA), facilitating ongoing enhancements to our products and services.

Additionally, Bio/Data Corporation actively supports global initiatives aimed at standardizing test performance and establishing harmonized interpretive guidelines. With laboratories worldwide relying on Bio/Data Corporation's aggregometers and reagents, laboratory professionals can consistently achieve precise hemostasis monitoring. This is accomplished by conducting platelet function and activation tests under uniform conditions, ensuring reliable results time after time. As a dedicated manufacturer and distributor of hematological medical laboratory products, our company remains steadfast in its commitment to continually enhance and refine its test systems.

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