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Medical Device Product Development and Realisation

8-week online course | 2 hours per week

7 May - 9 July 2019

Online Academy

With the expected publication of the Medical Device Regulation in 2017, the medical device industry is now undergoing a great deal of change. This flexible online course offers students an excellent opportunity to understand the entire medical device product lifecycle in the context of these pending updates.

This course will allow you to engage with and learn from a range of leading experts in the field and come to grips with regulatory affairs, quality management systems, risk assessments, clinical evidence requirements and commercial aspects of medical devices.

The new MDR will necessitate a degree of transformation to the medical devices industry, including changes to classification and essential requirements for proving compliance, among others. Designed for those new to medical devices, or needing a broad overview, this course will cover a variety of major topics to give an excellent understanding of the area.

• Introduction to the new Medical Devices Regulation
• Classification for medical devices
• General safety and performance requirements
• Technical documentation
• Understanding conformity assessment routes
• Performing a risk assessment
• Preparation and strategy for audits
• Overview of vigilance requirements
• Changing roles for economic operators
• Introduction to Clinical Evaluations
• Understanding Clinical Investigations

This course is designed for all professionals wishing to improve their knowledge of the medical devices arena, whether you are new to this or currently work in a related area, or would benefit for your future career development.

Professionals already experienced in the medical devices industry may also benefit from the course as an introduction to the new Medical Devices Regulation. 

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 


Over 8 weeks students will learn through:

  • 14 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months after the end of the course
  • Access the discussion forum to interact with other students
  • Direct contact with the trainers through the forum during the 8 weeks the course is running
  • Additional content such as course materials available to download

The modules were clear and concise and allowed me to get a much better understanding of the Medical device world as well as the MDR.

Bioengineering specialist, University of Surrey

This online academy course can be accessed from 7th May 2018. 1-2 modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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