QUALITY MANAGEMENT SYSTEM

ISO 13485:2003 Quality System Certificate

ISO 9001:2008 Quality System Certificate

 

PRODUCT REGISTRATIONS AND CERTIFICATIONS

AUSTRALIA - Devices listed in ARTG
Film Digitizers

CANADA - Medical device licenses
Film Digitizers

CHINA - SFDA

CHINA - CCC Mark

EUROPE - Declarations of Conformity
Film Digitizers: Advantage Family | SIERRA Advantage  
Microarray Scanner 4550 | Microarray Scanner 4200 | ClinicalExpress

 

GLOBAL REGULATORY REPRESENTATIVES

EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com

 

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

VIDAR Systems Corporation maintains ISO 13485:2003 + CMDCAS Certification for its medical devices and is audited every year by:

BSI Management Systems America, Inc.
Reston, VA
Telephone: 1.800.862.4977
http://www.bsiamerica.com/