United States [ Change ]Excellence in Quality
Quality System
Third Wave Technologies is highly committed to quality and customer satisfaction. The company's quality system is intended to assure that design, development, manufacturing, and distribution activities produce consistently high quality products that meet or exceed customer requirements.
Quality Policy
We are committed to consistently fulfilling our customer's needs by providing the highest quality products and services. We meet this challenge with talented employees, superior technology, effective quality systems, and compliance with all applicable regulations.
Quality Objectives
We consistently fulfill the needs of our customers, our employees, our stockholders, and our community by:
- Our commitment to consistently deliver superior technology to our customers through our vigorous design and development process.
- Our commitment to establish and maintain an effective Quality System that allows us to deliver the highest level of customer satisfaction and to demonstrate compliance with laws and regulations applicable to our products, our employees, and our business.
Global Compliance to Regulations and Standards
In order to assure the safety, effectiveness, and quality of our products, Third Wave meets or exceeds all applicable standards and regulations, domestic and international including:
US Food and Drug Administration (FDA), Quality System Regulations
Third Wave Technologies is a registered establishment with the FDA. The company follows Good Manufacturing Practices in the development and manufacturing of products.
Establishment Registration Listing
ISO Standard
Third Wave Technologies possess an ISO 13485:2003 Certification, a stringent globally recognized standard of quality management given to medical device manufacturers. This provides a solid competitive advantage as well as the ability to market products internationally. In addition, the certificate holds a "CMDCAS Recognized Registrar" logo, which represents Third Wave's compliance to the Canadian Medical Device Regulations.
European Union (EU) Regulations
Third Wave Technologies complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC).