Quality System & Standards

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:
  • 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.

Standards

A standard is an agreed, repeatable way of doing something. It is a published document that contains a technical specification or other precise criteria designed to be used consistently as a rule, guideline, or definition. Standards help to make life simpler and to increase the reliability and the effectiveness of the many goods and services we use. They are intended to be inspirational - a summary of good and best practice rather than general practice. Standards are created by bringing together the experience and expertise of all interested parties such as the producers, sellers, buyers, users and regulators of a particular material, product, process or service

FDA Quality System Regulations

Bio/Data Corporation adheres to the requirements of the current good manufacturing practices (cGMP) of the U.S. Food and Drug Administration (FDA). These requirements relate directly to the methods used in the quality control of designing, manufacturing, testing, packaging, labeling, storing, installing, and servicing of the in-vitro medical devices offered by the company.

CE Declaration of Conformity

ce

The CE Mark certifies that a product has met the European Union's (EU) health, safety and environmental requirements.

Authorized European Representative

emergologo

Prinsessegracht 20
2514 AP, The Hague
The Netherlands

Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
Website: www.emergogroup.com

ISO Certifications / Registration

isoBio/Data Corporation voluntarily adopted the ISO Quality Management System Standards in 2004, and continues to comply with those Standards. In 2005, the Company's Quality System was registered compliant with the ISO 9001:2000 Standard. 

Shortly after registration to ISO 9001:2000 the Company added ISO's medical device specific Standard as an objective for its Quality Management System and attained 13485:2003 registration in 2006. This Standard requires that a company demonstrate its ability to consistently produce medical devices that meet both customer and regulatory requirements.

BSI Management Systems, the Company's accredited ISO registrar, audits our quality systems. product performance, regulatory status and customer satisfaction periodically to verify compliance to the current versions of each Standard.

ISO 13485:2016 Certificate

iso_13485_2003

Bio/Data Corporation's Quality Management Systems are compliant with ISO Standard 13485:2016.

Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical 

device manufacturers.

Health Canada Licenses

health_canada

Bio/Data Corporation has received Class II Medical Device Licenses from Health Canada for the Company's Platelet Aggregometers, vW Factor Assay® (von Willebrand Factor Assay) products and all of its aggregation reagents. These Health Canada licenses recognize that our quality system conforms to all of their required standards.

South Korea Ministry of Food and Drug Safety GMP Certificate

Bio/Data Corporation has received a Certificate of GMP from the South Korea Ministry of Food and Drug Safety. This certifies that Bio/Data complies with South Korea Good Manufacturing Practices of Medical Devices for its product range of in-vitro diagnostic instruments and reagents.

Electrical and Laboratory Safety

Bio/Data Corporation's instruments and powered accessories meet required national, Canadian and international standards.

Clinical Laboratory Standards Institute (CLSI)

clsiBio/Data supports CLSI goals for improving laboratory performance, harmonizing quality standards and recommends that its customer laboratories adopt CLSI Approved Standards and Guidelines. For more Information, refer to our Reagent Technical Bulletins reference section for applicable approved standards and guidelines.

NASCOLA and CAP

nascola_cap college_america_pathologists

  Bio/Data strives to provide products that help clinical laboratories meet      required performance standards for producing accurate and precise laboratory results. Bio/Data participates in the same proficiency testing programs that many of our customers rely on as performance indicators. Proficiency testing programs regularly send "unknown" samples to participating laboratories that then test the samples and report results back to the sponsoring organizations. The reported results are graded and compared. It is this inter-laboratory comparison that laboratories use to evaluate their performance. NASCOLA (North American Specialized Coagulation Laboratories Association) and CAP (College of American Pathologists) are the two leading organizations that offer proficiency testing for hemostasis, coagulation and platelet function testing. Bio/Data participates in both programs.

BSI British Standards

bsiAs the world’s first national standards organization, BSI British Standards has a globally recognized reputation for independence, integrity and innovation in the production of standards and information products that promote and share best practice. It is a leading provider of standardization and consortia services to the public and private sectors, serving the interests of a wide range of industry sectors as well as governments, consumers, employees and society overall, to make sure that British, European and international standards are useful, relevant and authoritative.