Introduction to Clinical Evaluation Reports (CER) for Europe
In this video we'll explore the different aspects of a CER including what it is, why it is needed, an overview of the research process, and finally its contents and formatting.
Introduction to ISO 13485 Compliance for Europe
In this video we will learn more about the background of this global quality management system standard, and the steps you can take to obtain ISO 13485 certification in Europe.
Introduction to Canada's Medical Device Registration Process
Canada is a well-established but lucrative market for medical devices. This 4 minute video explains the medical device registration process in Canada, and the process for gaining approval from Health Canada.
Introduction to US FDA Medical Device Regulatory Process
The United States is the number one medical device market in the world. This 4 minute video explains the medical device registration process in the USA, and the process for gaining approval from the FDA.
PMS and PSUR Requirements Under the European MDR
This whitepaper presents the new MDR requirements regarding PMS obligations and the risks resulting from their implementation in a global QMS.
Understanding Europe's New Medical Device Regulation - MDR 2017/745
In this white paper, take a look at MDR 2017/745 and how it will impact medical device manufacturers.
Brexit at Work: Placing Medical Devices and IVDs on the UK Market
This white paper references the EU-UK Trade Agreement signed in December 2020 and the available guidance documents to provide a roadmap for marketing medical devices and IVDs in the UK post-Brexit.
MHRA - UK Medicines and Healthcare Products Regulatory Agency
MHRA overview. Read more about UK’s medicines and healthcare products regulatory agency and see the most important medical device regulations
South Korea Medical Device Regulatory Strategy Report
Let Emergo by UL assist you in evaluating the South Korean medical device regulatory framework as it applies to your device(s).
Singapore Vigilance Reporting for Medical Devices
Emergo by UL can help you implement a vigilance system for adverse event reporting, recalls and post-market monitoring as required by the HSA.