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 and Types of Testing

Company Name Biocompatability Testing Electrical Safety / EMC / Laser Testing Packaging and Sterility Testing Mechanical & Performance Testing
BSI   X    
CEcert GmbH   X    
Intertek   X   X
Knight Mechanical Testing       X
Medical Engineering Technologies (MeT) X   X X
Met Laboratories   X   X
Nelson Labs X   X  
Pacific BioLabs X   X  
SGS X X X X
Sherry Laboratories     X X
TÜV Rheinland   X   X
TÜV SÜD   X   X
Underwriters Laboratories (UL) X X X X
Washington Labs   X   X
WuXi AppTec X   X  

Quality System and Product Certification

Company Name 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
DQS Medizinprodukte GMBH   ISO 13485:2003 CCC Mark CE Marking JPAL ORD. 169   GOST-R
Intertek   ISO 13485:2003 CCC Mark CE Marking   NOM GOST-R
LNE/G-MED   ISO 13485:2003   CE Marking      
LRQA Inc.   ISO 13485:2003   CE Marking      
MedCert       CE Marking
 
JPAL ORD. 169    
NSAI   ISO 13485:2003   CE Marking      
SAI Global Certification Services   ISO 13485:2003 CCC Mark CE Marking      
SGS   ISO 13485:2003   CE Marking     GOST-R
TGA   ISO 13485:2003          
TÜV NORD CERT GMBH   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
TÜV USA   ISO 13485:2003          
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.