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.

Starting 5 October 2020

5-week online academy

Learn about Safety & Security Risk Management, Design Control, Clinical Evaluation and Usability Engineering for Health apps and Medical Device Software

Course Overview

Are you aware of the methodologies available to identify and manage risk associated with your software? Is your software product compliant with the recent usability and effectiveness guidelines laid out in the Medical Device Regulation (MDR)?

Health software qualifying as a medical device must comply with the general safety and performance requirements (GSPR) pertaining to safety and security. In addition, under the MDR, developers must demonstrate compliance with development guidelines (such as IEC 62304 & IEC62366) ensuring user-friendly and effective devices. Using practical examples, this 6-module course teaches you bes tpractices to apply EU safety and security regulations ensuring your device is fully compliant. You will also learn various testing and evaluation strategies outlined in the MDR to create apps and software that meet usability and effectiveness requirements.

If you are involved in the development of health software, or responsible for regulatory or developmental control, then this course details everything you need to know to ensure you are compliant with the evolving MDR.

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 5 weeks students will learn through:

  • 6 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

What will you learn?

Cybersecurity for health apps
Cybersecurity for health apps

Understand the importance of cybersecurity for health apps by learning about the key principles of data integrity

How to minimise risk
How to minimise risk

Learn to minimise safety and security risks by applying methodologies detailed under GSPR

Key risk management strategies
Key risk management strategies

Understand key risk management strategies to adequately identify safety and security risks associated with your software

Project management
Project management

Develop your project management techniques to maximise the efficiency of your daily processes and effectively design your device

International standards
International standards

Build-on your knowledge of the International Standards relating to the usability of your software device

Clinical investigations, evaluations and post-market activities
Clinical investigations, evaluations and post-market activities

Discover key considerations for clinical investigations, evaluations and post-market activities for your device

Tools for design
Tools for design

Apply a range of different software platforms, plugins and design controls to your own health app or software

Who is this course for?

This course is a suitable follow on for attendees from ‘Navigating the Regulations’ online course and is also suitable for professionals who work in software development who wish to further their understanding of how to apply the EU regulations to their product. Popular areas include:

  • Regulatory Affairs
  • Quality control
  • Software Development
  • Software Engineering
  • Clinical Evaluators
  • Post-market vigilance

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...

for quality of content
applied content during the course to their role
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

Examples of books and eBooks within medical devices include:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Instruments and Devices: Principles and Practices
  • Usability Testing of Medical Devices
  • Nanotechnology in Biology and Medicine: Methods, Devices, and Applications, Second Edition
  • And more