Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

EUROPE - Authorized Representative
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
http://www.EmergoGroup.com

Registrar/Certification Body

ARK Diagnostics Inc. maintains ISO 13485:2003 certification and is audited every year by:

BSI Management Systems America, Inc.
Reston, VA, USA
http://www.bsiamerica.com

Note: To access Package Inserts, Safety Data Sheets, Certifications, and Approvals, go to the ARK™ Products and select the specific assay.

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)

ARK Diagnostics Inc. seeks regulatory clearance in the United States and Internationally.