The hallmark of Fujirebio Diagnostics, Inc., is our ability to develop and produce products of the highest quality. All processes involved in the life of our products, from concept through design, manufacturing, distribution, and use, follow the ISO 13485:2003 quality management system for medical devices. In addition, our corporate facility in Malvern, PA, is cGMP compliant and ISO 140001 certified.
Fujirebio Diagnostics EIA in vitro diagnostic kits are CE marked and meet all necessary requirements. Our facility in Seguin, TX, is a FDA registered contract manufacturer and manufactures all products in compliance with the Quality System Regulations (QSRs). All processes are documented in Device History Records (DHR) according to approved Device Master Records (DMR).
Following is our complete list of manufacturing certificates:
- ISO 13485:2003 - Malvern, PA
- ISO 9001:2008 - Seguin, TX
- ISO 13485:2003 - Seguin, TX
- ISO 13485:2003+AC2007 - Seguin, TX
- ISO 13485:2003 CMDCAS - Malvern, PA
- EC Directive 98/79/EC Annex IV, Article 3 - Gothenburg, Sweden
- ISO 13485:2003 CMDCAS - Gothenburg, Sweden
- EN ISO 13485:2003+AC:2007 - Gothenburg, Sweden