QUALITY POLICY

We, as TEI Biosciences Inc. employees, are committed to building quality partnerships with our customers and suppliers. We do this by consistently designing, developing and manufacturing products that meet, or exceed, our customers' expectations.

We will continuously manage and improve our business processes based on meaningful measurments incorporating our customers' requirements for quality.

COMPLIANCE

TEI has established a quality system that complies with international and national quality system standards, including:

21 CFR Part 803, Medical Device Reporting
21 CFR Part 820, Quality System Regulation
ISO 13485:2003
- Quality Systems - Medical Devices - Particular requirements for the application of ISO 9001
- Design, Production and Distribution of Nonactive Implants for Soft Tissue Repair
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive)

All documents and procedures encompassed within the TEI quality system comply with these requirements.

For more information about TEI quality systems, please call customer service at 1-866-524-0022, or e-mail .