Regulatory Compliance

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.

EUROPE - Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299
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
Telephone: (703) 437-9000
http://www.bsiamerica.com

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.