Quality Management System
ARK Diagnostics Inc. is committed to an effective, certified quality management system and is fully compliant with the following Quality System Regulations:
- ISO 13485:2003 CMDCAS quality system certification
- California FDB Device Manufacturing License
- US FDA Good Manufacturing Practice (GMP): 21 CFR Part 820
- Canadian Medical Devices Regulations (CMDR), SOR/98-282
- EC Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD)
Global Regulatory Representatives
Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
ARK Diagnostics Inc. maintains ISO 13485:2003 certification and is audited every year by:
BSI Management Systems America, Inc.
Reston, VA, USA
Telephone: (703) 437-9000
Note: To access Package Inserts, Materials Safety Data Sheets, Certifications, and Approvals, go to the ARK™ Products and select the specific assay.
ARK Diagnostics Inc. seeks regulatory clearance in the United States and Internationally.