eBOOK: Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745

Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745 is officially available as an eBook! Buy it now!

$75.00

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Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745

New and emerging technologies together with so many well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise in recent times. For this reason, there has been an increasing need to update the Medical Device Directive 93/42/EEC in Europe. This has led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This volume aims to provide an easy-to-understand guide for beginners to the new medical device regulations in Europe. It looks specifically at changes between the current Medical Device Directive 93/42/EEC and new Medical Devices Regulation (EU MDR 2017/745) with regards to classification, conformity assessments and assessing general safety and performance requirements.

$75.00

In this book we’ll look at an easy-to-understand guide for beginners to the new Medical Device Regulation (MDR2017/745) in Europe.

We’ll cover, in detail, changes between the current Medical Device Directive (MDD 93/42/EEC) and Medical Device Regulation (MDR 2017/745) with regards to classification, conformity assessments, and assessing General Safety and Performance Requirements (GSPR).

You’ll learn about what governs the safety of medical devices in Europe and what you need to do to ensure your device complies.

In this book you’ll learn about:

  • Medical Device Classification according to the European Medical Device Classification Rules
  • Changes to the classification rules under the new Medical Device Regulation
  • How Conformity Assessments work
  • How to determine the best compliance route for your device
  • What each GSPR (General Safety and Performance Requirement) means
  • What are the major differences between the Medical Device Directive and the Medical Device Regulation

Get your eBook today!

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Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745

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

$75.00