Medical Device Regulation (MDR): Intro for Device Designers

An introduction to the EU's Medical Device Regulation (MDR) for those involved in developing medical devices

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Medical Device Regulation (MDR): Intro for Device Designers

What You Will Learn!

The overall requirements and structure of the Medical Device Regulation (MDR)
Understanding the structure and content of the related international standard on Medical Device Software EN 62304
Understanding the structure and content of the related international standard on the Application of Risk Management to Medical Devices ISO 14971
What are the general safety and performance requirements set out in the MDR

Description

Welcome to this short video series introducing the European Union's Medical Device Regulation (MDR). If you’re involved in the design and development of medical devices and are looking to get up to speed on this current regulation hopefully you’ll find this series useful.

What's In

We run through a lot of the topics covered in the MDR starting at what specifically count as medical devices, what rules govern the marketing claims which can be made about them and how development for the MDR relates to international harmonised standards. We introduce a lot of the obligations placed on us as designers and manufacturers including technical documentation, traceability, risk management and a lot of other content I hope you’ll find useful. We also signpost where you can find more detail on each topic as we go along.

What out

In this series, we focus more on aspects of the MDR relevant to design and development of devices in preparation for sale rather than, distribution, post market requirements, or the requirements placed on notified bodies which are also covered in the MDR.

Who's it for?

Whether you’re just getting started in the medical device industry or looking to get up to date on this latest regulation, hopefully you will find this series useful and it will help take your learning to the next level.