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  • Video

The New European Medical Devices Regulation (MDR 2017/745)

The first major revision to device regulations since 2007 has been released and the changes are significant. Smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute.
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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.
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  • Video

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.
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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.
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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.
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