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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.
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.
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.
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.
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.