Global Regulatory Representatives

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

EUROPE - Authorized Representative
Emergo Europe B.V.
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
https://www.emergobyul.com/

Registrar/Certification Body

ARK Diagnostics, Inc. maintains ISO 13485:2016 certification and is audited every year by:

BSI Group America Inc.
Herndon, VA, USA
https://www.bsigroup.com/en-US/

Note: To access Package Inserts, Safety Data Sheets, Certifications, and Regulatory Clearance, 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 13485:2016 Quality System Certification
MDSAP 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.

Regulatory Compliance

Global Regulatory Representatives

Registrar/Certification Body

Quality Management System