Regulatory Info


Regulatory Compliance Information

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

EUROPE - Declarations of Conformity
Medical Film Digitizers
ClinicalExpress
NDTPRO Industrial Film Digitizer

 

GLOBAL REGULATORY REPRESENTATIVES

EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570

http://www.EmergoGroup.com

 

REGISTRAR

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

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

VIDAR Systems Corporation   365 Herndon Parkway   Herndon, VA 20170
Phone +1.703.471.7070   Fax +1.703.471.7665   Toll-free 800.471.7226
VIDAR_Corp 3D_Systems