This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Starting TBC in 2021

4-week online academy

Improve your understanding of the latest risk requirements and responsibilities outlined in the MDR

Course Overview

Risk management is a complex but necessary process for medical device companies, and its complexity has only heightened with the introduction of more stringent regulatory requirements under ISO 14971 and the Medical Device Regulation (MDR). It is crucial to learn how to correctly modify your approach so that you are harmonised with the new Regulations and can guarantee your compliance.

This online course will provide you with a complete overview of the key regulatory considerations for risk accompanied by the tools and techniques you can use to implement them, for both professionals new to the area and those who need an update on the latest developments. You will be able to cement this knowledge through an entire module on case studies based on the trainer’s own experiences, so you can practically apply the information you have learned.

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:

  • 4 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?


Requirements under the MDR
Requirements under the MDR

Update your knowledge of the risk requirements in the new MDR

The regulatory standards
The regulatory standards

Understand the importance of ISO 14971 and how to apply it to your own processes and Identify links between ISO 14971 and ISO 13485

Risk management
Risk management

Develop your skills in risk management planning by learning about key project management methodologies

Who is this course for?

This course will be useful for personnel involved in risk assessment and risk management activities, and for those who are new to the industry and need a complete overview of the medical device regulatory framework in the EU. It will be applicable for professionals in:

  • Regulatory affairs
  • Quality assurance
  • Product managers
  • Design engineers
  • Clinical staff
  • Project managers

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:

  • ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
  • ISO 9001: 2015 - A Complete Guide to Quality Management Systems
  • Medical Device Quality Assurance and Regulatory Compliance
  • Design Controls for the Medical Device Industry, Third Edition
  • And more