Regulatory Compliance Information Print

QUALITY MANAGEMENT SYSTEMx

ISO 13485:2003 Quality System Certificate pdfminilogo.jpg

ISO 9001:2008 Quality System Certificate pdfminilogo.jpg

 

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 pdfminilogo.jpg | SIERRA Advantage pdfminilogo.jpg 
Microarray Scanner 4550 pdfminilogo.jpg | Microarray Scanner 4200 pdfminilogo.jpg | ClinicalExpress pdfminilogo.jpg

 

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/

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