Quality System

BIO/DATA CORPORATION

An ISO 13485:2003, 9001:2000 Registered Company

QUALITY SYSTEM

Bio/Data's Quality Policy is to produce products and services that meet customer
expectations for performance and provide a maximum level of customer satisfaction. This
policy is implemented to maintain strong customer satisfaction and to reinforce quality
assurance , quality control, and good business practices.

To affirm this commitment, Bio/Data 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 CFR Title Section
800 to 899) and is registered by BSI North America (British Standards Institution) to the ISO
9001:2000 and ISO 13485:2003 quality standards. Our products are manufactured to
conform to the EU 98/79EC Directive and the Canadian SOR/98282 Medical Device
Regulations. These quality assurance regulations and programs permit for worldwide
marketing of our products.

As 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.

Bio/Data Corporation's Quality Assurance System Concentrates on providing:

Defect-free products and services to our customers.

On time delivery.

Continual improvements to all aspects of our Quality Assurance System, products,
and services.

How does Bio/Data Corporation measure its commitment to Quality and the realization
to its quality goals?

Timely and periodic review by management of the data generated by the Quality
Assurance Systems. These reviews generate Corrective and Preventative Actions
(CAPA) that improve our systems, products, and services.

Timely and periodic review of reports detailing the Company's delivery performance.
The Management team develops policies and procedures for improvement if and
when needed.

An ISO 13485:2003, 9001:2000 Registered Company

155 Gibraltar Road, PO Box 347, Horsham, PA 19044-0347 USA
(215) 441-4000 Worldwide / (800) 257-3282 USA / (215) 443-8820 Fax Worldwide
Website: www.biodatacorp.com / Email: customer.service@biodatacorp.com