Committed to Quality
We are committed to delivering high quality products with outstanding value built on the foundation of a dynamic goal-oriented quality management system. Our continual investment in quality ensures that we exceed the expectations of our shareholders, customers, partners, key stakeholders, and employees.
Our quality management system is ISO 9001:2008 and ISO 13485:2003 certified, compliant with the United States Food and Drug Administration’s current Good Manufacturing Practices (cGMP: Quality System Regulation Part 820 of CFR Title 21, Volume 8), European Union’s Directive 98/79/EC on in vitro diagnostic medical devices, and Health Canada Medical Device Regulations (SOR/98-282).
Additionally, we adhere to ISO 14971 (Application of Risk Management to Medical Devices) and ISO 2859 (Sampling Procedures for Inspection by Attributes). Certification and compliance to these requirements attests to our ability to maintain the highest standard of quality in medical device manufacturing, product development and corporate conduct.
Our rapid tests have been evaluated and approved by a broad range of health regulators and agencies including:
United States Food & Drug Administration
China Food and Drug Administration, P.R. China
European Union CE Mark
United Nations Agencies
- UN Development Programme (UNDP)
- UN Population Fund (UNFPA)
- UN Office for Project Services (UNOPS)
- UN Office at Vienna (UNOV)
- International Trade Centre (ITC)
United States Agency for International Development
Pan American Health Organization