UL International Germany GmbH

Endorse Company
Underwriters Laboratories Health Sciences Division UL provides comprehensive testing, regulatory, inspection, audit and certification services to support medical and IVD companies with global regulatory submissions. Our local services include integrated systems certifications for ISO 13485, Canada CMDCAS, European Notified Body, Japan - PAL, Brazil – INMETRO and Risk Management ISO 14971. Our experienced engineers provide safety assessments to IEC 60601, IEC 61010, Home-Healthcare and CB Scheme. Our Human Factors Engineering experts provide usability testing and assessments per HE-75, IEC 62366 and IEC 60601-1-6. Our testing institute conducting performance and safety tests on medical devices for manufacturers is EN ISO/IEC 17025 accredited and GLP certified. We specialize in clinical and non-clinical investigations and help medical device manufacturers to obtain CE-marking and international market authorisations for their devices. With global resources, we can provide custom supply chain services to help you save time and mitigate risk. Find out more: www.ul.com/medical

Products