Certifications

Quality and Environmental Management System Certifications


  Issue Date Expiry Date Agency Standard
10/16/2009   WI Department of Natural Resources Green Tier 1
11/2/2009 11/2/2012 ITS-Intertek ISO 13485:2003
11/2/2009 11/2/2012 ITS-Intertek ISO 9001:2000
12/18/2007 12/18/2012 SEMKO-ITS Annex V EU Medical Device Directive (93/42/EEC)

Facility Registrations


Agency Standard
U.S. Food and Drug Administration Establishment Registration 2184007
Health Canada Medical Device Establishment License 946
US Nuclear Regulatory Agency Material License 48-32389-01
WI Department of Health Services Material License 025-1304-01