Market Access Services from Emergo by UL

© 2019 EMERGO by UL. All Rights Reserved.Privacy Terms of Use

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.

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EU MDR compliance consulting for cosmetic and aesthetic products

EU Medical Devices Regulation 2017/745 (MDR) preparation support and resources

Brexit Transition Consulting for Medical Device and IVD Companies

GCP and ISO 14155 Compliance Consulting for Medical Device Clinical Studies

Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

On-Site Medical Device Single Audit Program (MDSAP) Training for Manufacturers

On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers

Human Factors Engineering (HFE) and Usability Testing for Medical Devices

US FDA Official Correspondent for Medical Device Companies

EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Device Manufacturers

Medical Device Clinical and Testing Requirements Assessment for China

Medical Device Classification Consulting and Japan JMDN Code Research

Australia TGA Prostheses List Application Preparation and Consulting

PMDA Registration for In-Vitro Diagnostics (IVDs) in Japan

ISO 13485:2016 consulting and gap analysis

© 2019 EMERGO by UL. All Rights Reserved.Privacy Terms of Use