Medical Device Regulatory Pathway Support for Smaller International Markets
From Algeria to Zambia, we provide custom Regulatory Pathway Reports for almost every country in the world, including Latin America, Southeast Asia, and Africa.
Medical Device and IVD Regulatory Affairs and Quality Consulting
With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements worldwide.
Global Registration Consulting for Medical Devices and IVDs
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device.
Clinical Evaluation Reports (CER) for Medical Devices
This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR. The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR).
2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland
Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.
2022 Outlook and Updates for the US Food and Drug Administration
Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.
Performance Evaluation – When, What and How to Prepare for EU IVDR
This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.
MDR Update: Common Themes from Medical Device Manufacturers
In this complimentary webinar, we examine resources developed by the European Commission.
Emergo by UL’s HFR&D Team: A Melting Pot of Backgrounds and Skillsets
Diversity of expertise, education and backgrounds drives our Human Factors Research & Design (HFR&D) division. Learn more at Emergo by UL.
Japan’s MHLW Updates Medical Device Program Display Code and Labeling Laws
Japanese medical device regulators have updated program codes and labeling rules.