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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

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Malaysia
Malaysia Emergency Use Pathways for Medical Devices
Medical devices and IVDs are regulated by the Medical Device Authority in Malaysia. The standard...
Europe
EU MDR compliance consulting for cosmetic and aesthetic products
ANSWERED ON THIS PAGE: Which cosmetic and aesthetic products fall under EU MDR requirements? How should my company prepare for MDR compliance?
Europe
EU Medical Devices Regulation 2017/745 (MDR) preparation support and resources
MDR will introduce major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market, and yet a majority of companies may have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies.
multiple markets
UK Responsible Person and Brexit consulting for medical device companies
ANSWERED ON THIS PAGE: What does the post-Brexit UK regulatory system look like? Do UK companies need in-country representation in the EU? How can medical device companies sell in the UK following Brexit?
Europe
MDR, IVDR and ISO 14155 clinical activity compliance support
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies carried out in human subjects.
multiple markets
Medical Device Single Audit Program (MDSAP) Internal and Gap Audits
ANSWERED ON THIS PAGE: What are the requirements for the Medical Device Single Audit Program (MDSAP)? Which countries are participating in the MDSAP? How can we achieve MDSAP certification?
multiple markets
On-Site Medical Device Single Audit Program (MDSAP) Training for Manufacturers
ANSWERED ON THIS PAGE: What does our quality team need to know about the MDSAP to participate in the program? Which quality documents and procedures should we update to prepare for MDSAP certification? Is there a cost-effective way to learn about the MDSAP system?
Europe
On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers
ANSWERED ON THIS PAGE: What do our employees need to know about the MDR to maintain compliance? How can we recertify to the MDR? Is there an efficient, cost-effective way to train our team on the MDR?
multiple markets
Human Factors Engineering (HFE) and Usability Testing for Medical Devices
ANSWERED ON THIS PAGE: What is Human Factors Engineering? What are the benefits of HFE for medical devices? Must we obtain specific certifications to comply with US FDA HFE requirements?
United States
US FDA Official Correspondent for Medical Device Companies
ANSWERED ON THIS PAGE: What is a US FDA Official Correspondent (OC)? How is an Official Correspondent different from a US Agent? Are we required to appoint an Official Correspondent?
Europe
EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Device Manufacturers
ANSWERED ON THIS PAGE: What are the deadlines for MDD to MDR 2017/745 compliance? What are the biggest changes in the EU Medical Devices Regulation (MDR)? How should my company manage the EU MDR transition process?
China
Medical Device Clinical and Testing Requirements Assessment for China
ANSWERED ON THIS PAGE: What are the medical device clinical data requirements in China? How do we...
Japan
Medical Device Classification Consulting and Japan JMDN Code Research
ANSWERED ON THIS PAGE: How are medical devices classified in Japan? How are IVDs classified? What are JMDN codes?
Australia
Australia TGA Prostheses List Application Preparation and Consulting
ANSWERED ON THIS PAGE: What is the Australia Prostheses List? What are the criteria to be eligible...
Japan
PMDA Registration for In-Vitro Diagnostics (IVDs) in Japan
ANSWERED ON THIS PAGE: What is the classification scheme for IVDs in Japan? How do regulatory requirements differ for Japanese vs. foreign IVD manufacturers? What are the IVD registration procedures in Japan?
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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.