UL International Germany GmbH

Admiral-Rosendahl-Str. 9, 63263 Neu-Isenburg
Germany
Telephone +49 69 489810-0
Fax +49 69 489810-168
medical.inquiry@ul.com
http://www.ul.com/medical

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Admiral-Rosendahl-Str. 9, 63263 Neu-Isenburg
Germany
Telephone +49 69 489810-0
Fax +49 69 489810-168
medical.inquiry@ul.com
http://www.ul.com/medical

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Company

Company details
UL provides the expertise to support medical and IVD companies meet project timelines for global regulatory submissions. We have a robust team of technical experts throughout Europe and locally in Germany ready to help you with your testing, certification, auditing and CE-marking needs.

Our services include dedicated auditors who can provide integrated systems registrations for ISO 13485, Canada CMDCAS, MDSAP, ICMED, European Notified Body, Brazil – INMETRO and Risk Management ISO 14971. Our experienced engineers provide safety assessments and testing for IEC 60601, IEC 61010, CB Scheme and more. We assess and test all aspects of connected devices safety including wireless, cybersecurity, interoperability and EMC.

Our Human Factors Engineering (HFE) experts provide usability assessments, training and testing.

Our pre-clinical experts and GLP laboratories are located in Germany and we have local study directors that provide testing and validation for sterility, shelf life, packaging, biocompatibility, ophthalmic devices and more.

We are also leaders in air quality testing and can test respiratory equipment and other devices and accessories that come into contact with the breathable air pathways to ISO 18562. We offer a GREENGUARD Certification to support regulatory submissions and environmental claims. www.ul.com/environment

Find out more: www.ul.com/medical

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