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CSA Group Company Profile

 
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www.csagroup.org
E: [email protected]
T: (866) 463 1785
F: (216) 328-8138

Address
8501 E. Pleasant Valley Rd., Independence, OH, 44131, United States
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Qualifications: ISO 9001, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe, Worldwide

 

CSA Group offers international medical equipment testing and certification services, including IECEE (CB Scheme), the FDA ASCA Pilot Program, and testing according to IEC 60601/80601 and ISO 80601 series of medical standards. With decades of experience working with the medical industry, CSA Group is well-versed in the latest international medical equipment standards, helping manufacturers comply with the FDA, Health Canada, EU MDR, CFDA, and other international regulatory body requirements. No matter where your facilities are in the world, our local experts can develop a testing plan and certification program that meets your needs and the requirements of your target market.

The end-to-end services that support your testing and certification projects include:

• Auditing

• Coexistence testing (per FDA)

• Custom testing and on-site testing

• Documentation review for risk management process

• EMC and radio testing

• Energy efficiency evaluation

• Usability engineering process review

• Environmental simulation testing

• Global Market Access

• In-depth training, including custom training

• Special Inspection/Field Evaluation



• Technical Information Service – information provided early in the design phase of product development regarding the applicable standards and requirements

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CSA Group

www.csagroup.org
E: [email protected]
T: (866) 463 1785
F: (216) 328-8138

Address
8501 E. Pleasant Valley Rd., Independence, OH, 44131, United States
View map

Follow  
LinkedIn
 
 

CSA GROUP CORPORATE HEAD OFFICE
178 Rexdale Blvd.
Toronto, ONTARIO
M9W 1R3
Canada
T 4167474000

CSA GROUP EUROPE GMBH
Weismüllerstraße 45
Frankfurt
60314
Germany

 
 
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