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Informa
Starting TBC in 2021

4-week online academy

Gain an in-depth understanding of how the new Medical Device Regulation will apply to clinical investigations of medical devices

Course Overview

To improve patient safety the Medical Device Regulation (MDR) puts a greater emphasis on clinical data to provide evidence of safety, especially for riskier products. As a result more clinical data is required by manufacturers, which in turn means more clinical investigations must be undertaken to generate the data.

But what is required to perform a trial?

What requirements must you follow?

How should the study be designed?

This 5 module course will examine the requirements and design protocols of clinical investigations for new devices with case study examples. You will learn also about post-market clinical follow-up studies for existing products and will look at the impact of the new Regulation.

Online Academies

MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 5 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Clinical Investigation planning
Clinical Investigation planning

Understand protocol and regulation around Clinical Investigation planning and conduct


Post-market clinical studies
Post-market clinical studies

Assess post-market clinical studies for existing products and examine how requirements will change with the new Regulation



Study design
Study design

Consider key factors for effective study design


PMCF
PMCF

Investigate PMCF study design and how to implement PMCF

Who is this course for?

This course is for professionals who are involved with clinical investigations in industry, consultancy, agencies, notified bodies, and within CROs. Delegates may include the following departments and job titles:

  • Regulatory affairs
  • Clinical development
  • Medical writing
  • Quality
  • Engineers
  • Scientists

Find out more about online academies...


MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.

Examples of books and eBooks within medical devices include:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Device Packaging Handbook, Third Edition
  • Medical Device Regulatory Practices: An International Perspective
  • Nanotechnology in Biology and Medicine: Methods, Devices, and Applications, Second Edition
  • And more