Regulatory Compliance
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 Renewal
- MDSAP Certification Renewal
- IVDR 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.
© Copyright 2025, ARK Diagnostics, Inc.