A Simple Guide to Understanding Medical Device Regulations is officially available as an eBook! Buy it now!



A Simple Guide to Understanding Medical Device Regulations

As innovation and rapid advancement in technologies take over, medical devices have now become one of the fastest-growing industries globally. Regulatory controls for medical devices are often complicated to implement due to the many different types of devices available on the market. Often the risks associated with each type of device differ, making the opportunity for misuse considerable. This simple guide will provide an overview of how regulatory systems work and what goes into implementing a such regulatory frameworks. It highlights the importance of long-lasting good governance and provides a step-by-step approach on the development of national regulatory programs for medical devices.


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In this book we’ll look at some of the guiding principles and essential features of a simple medical device regulatory program.

You’ll learn about what governs the safety of medical devices and who is responsible for implementation, applying conformity assessment rules and the use of standards to guide a regulatory model.

In this book you’ll learn:

  • How to classify a medical device according to the European Medical Device Classification Rules
  • Simplified explanations how to ensure safety of medical devices
  • How to assess the effectiveness and performance of medical devices
  • How Conformity Assessment of medical devices work
  • what is STED (Summary Technical Documentation)
  • An overview of what are Standards and why they are important
  • Who is The Global Harmonized Task Force and the International Medical Device Regulators Forum
  • How Nomenclature of Medical Devices works
  • Why regulatory controls are so complicated
  • How to establish a basic regulatory program

Get your eBook today!

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A Simple Guide to Understanding Medical Device Regulations

Get your eBook today! After payment has been received, you will receive a PDF version that is available for download.