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
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
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
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.