- Course Overview
What you'll 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.
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About the instructors
- 4.44 Calificación
- 1984 Estudiantes
- 1 Cursos
James Holmes
Engineer
James is an electronics and software engineer with 12 years of experience developing technology solutions for applications ranging from autonomous robotics to medical devices. He has a PhD in the field of power electronics and he has extensive experience of medical device development from drug delivery devices to diagnostics products.
Student feedback
Course Rating
Reviews
Knowledgeable for all individual who are involved in medical device field
clear explanation
The overview of regulations affecting medical devices is good.
Die wesentlichen Markmale des Risk Management wurden angesprochen und mit den Begriffen der Norm erklärt