ISO 13485 Regulatory
Quality Managment System
ISO 13485 Quality System Certification (PDF Format)
ISO 13485:2003 Certificate

Product Certifications and Approvals
EUROPE - Marking Certificates
CE Certificate
.jpg)
Global Regulatory Representatives
EUROPE - Authroized Representative
![]()
Emergo Europe
The Hague, Netherlands
Telephone: +21.70.345.8570
www.EmergoGroup.com
Notified Body / Registrar / Certification Body
Custom BioGenic Systems maintains ISO 13485:2003 certification and is audited every year by:
BSI British Standards, Customer Services
![]()
389 Chiswick High Road
London
W4 4AL
United Kingdom
Telephone: +44 (0)20 8996 9001
Fax: +44 (0)20 8996 7001
www.bsi-global.com




