Medical Device Regulations

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Medical Device Regulations, Learn about the medical device industry and how to bring new products to market 510K, PMA, De Novo, ISO13485 and beyond!

The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space.

We will cover all of the key components of bringing a new device to market, including:

  • Paths to Market, including the 510K, PMA, HDE and other commonly used pathways
  • Clinical trials of medical devices, including IDE, submissions, records and reporting
  • Risk management and quality in device development

During this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.

This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.


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