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Informa
Starting 5 October 2020

4-week online academy

Navigate through the EU Regulations to know how to classify your software and identify regulations which are relevant to you

Course Overview

Navigating the regulations that surround health software products and services is challenging with little information available to developers. It is important to understand which laws and regulations apply to you and remain up to date with their changes. Over 4 modules you will gain a solid understanding of the European regulatory requirements that affect not just mobile phone apps, standalone software or cloud computing services but also artificial intelligence, firmware for medical devices and plugins that run on consumer electronics or on platforms part of the Internet of Things. You will learn which requirements are relevant to your software products and services and be in a better position to know the optimal route to market them.

Delegates who attend this course would also find the following two courses beneficial:

  • Creating Safe & Secure Health Apps & Medical Device Software
  • Creating User-Friendly & Effective Health Apps and Medical Device Software

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?


How to classify your software/app
How to classify your software/app

Familiarise yourself with the current classification system for medical devices, and know which class your software belongs in

Definitions
Definitions

Learn definitions of various software and apps including: standalone software, mobile applications, IVDs, active implantable


EU Regulations
EU Regulations

Understand the EU Regulatory landscape, and know how to navigate these regulations and identify which ones are relevant to you

How to launch to market
How to launch to market

Assess the various routes to market for a software/app when it is a device: CE marking, Notified Body, conformity assessment.

Who is this course for?

This is an introductory course applicable to people working in medical software and health app development and regulations. Departments include:

Regulatory Affairs

Software Developers

Software Engineers

Medical Device Developers

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.