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Medical Device Testing, QMS and Product Certification

Shown below is a list of companies well known for providing various types of medical device testing, Quality Management System (QMS) and product certification. We encourage you to evaluate several of these providers as they are all well respected. However, Emergo Group does not endorse any specific company.

Medical Device Testing Labs

Company Biocompatability Testing Electrical
Safety/EMC/
Laser Testing		 Packaging and Sterility Testing Mechanical &
Performance
Testing
BSI
   X    
Intertek
   X   X
Knight Mechanical Testing
       X
Met Laboratories
   X   X
Nelson Labs
 X   X  
SGS
 X X X X
TÜV Rheinland
   X   X
TÜV SÜD
   X   X
Underwriters Laboratories (UL)
 X X    
Washington Labs
   X   X
WuXi AppTec
 X   X  

Quality System and Product Certification

Company BRAZIL CANADA CHINA EUROPE JAPAN MEXICO RUSSIA
BSI
 INMETRO ISO 13485:2003   CE Marking JPAL
ORD. 169		 NOM GOST-R
DEKRA
   ISO 13485:2003 CCC Mark CE Marking     GOST-R
Intertek
   ISO 13485:2003 CCC Mark CE Marking   NOM GOST-R
LNE/G-MED
   ISO 13485:2003   CE Marking      
MedCert
       CE Marking
 		      
NSAI
   ISO 13485:2003   CE Marking      
SGS
   ISO 13485:2003   CE Marking     GOST-R
TÜV Rheinland
 INMETRO ISO 13485:2003   CE Marking JPAL
ORD. 169		 NOM GOST-R
TÜV/SÜD
   ISO 13485:2003   CE Marking JPAL
ORD. 169		   GOST-R
Underwriters Laboratories (UL)
 INMETRO ISO 13485:2003   CE Marking JPAL
ORD. 169		 NOM GOST-R

Note: We do not list a company as having expertise in a specific market if they are providing that service through a partnership with another firm.