CSA Group Europe GmbH

Weismüllerstr. 45, 60314 Frankfurt
Germany
Telephone +49 69 509571555
Fax +49 69 509571999
client.services@csagroup.org

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07 Medical Services and Publications
07.10 Technical equipment management, Test houses / Certification Bodies
MEDICA 2017
Technical equipment management, Test houses / Certification Bodies

Testing and Certification Services for Medical Products
1 Product

07 Medical Services and Publications
07.10 Technical equipment management, Test houses / Certification Bodies
07.10.02 Certification and testing of medical devices, quality assurance
MEDICA 2017
Certification and testing of medical devices, quality assurance

Testing and Certification Services for Medical Products
1 Product

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Contact Us

Daniel Krieger
Marketing Manager, Healthcare
Email
daniel.krieger@csagroup.org

Marcel Laven
Technical Account Manager
Email
marcel.laven@csagroup.org

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Company

Company details
CSA Group is a leading internationally accredited provider of testing and certification services for North American and global market access. For more than 95 years, we have helped our clients obtain relevant safety approvals for their products to get them to patients and healthcare professionals all over the world, faster and more predictably.

As a global leader in conformity assessment services for medical equipment, we provide access to experienced, highly knowledgeable and committed technical experts at all stages of product development. Supported by many years of experience in developing standards and codes, we test and certify medical products, such as electromedical devices and test,lab & measurement equipment, according to

IEC 60601-1 (2nd & 3rd Edition)
IEC 61010-1
CB-Scheme
In addition, our service scope includes

Global Market Access for electro-medical equipment incl. Europe, South America, Asia, Australia and Russia
Testing and Certification for rebuilt electro-medical equipment
Support for technical documentation of medical devices based on the Medical Device Directive (MDD)
Evaluation service during product development process
Risk Management Process Assessment according to ISO 14971
Usability Assessment of electro-medical devices according to IEC 62366
CE conformity testing
Technical Information Service (TIS) to review standard requirements
Electromagnetic Compatability (EMC) testing of electro-medical devices
Custom training to the Medical Device standards
and many more
Our extensive technical knowledge, fast turnaround times and global recognitions and accreditations help you achieve your goals for increased efficiency, speed to market and market access, so that your products reach healthcare specialists and patients all over the world safely and within reliable timeframes.

For more information on CSA Group, please visit www.csagroup.org

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