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Health Apps and Medical Device Software - Online Academy

4 week online course beginning on 5th November 2018

Online Academy

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.

Watch the introduction to this new course and what will be covered

Koen Cobbaert

Koen chairs the COCIR’s software task force. During his time with the organisation he has co-authored the 1st and 2nd edition of MEDDEV 2.1/6 on the qualification and classification of standalone software. He has also been heavily involved with the classification guidance for Software in Rule 10 and 11 under the Medical Device Regulation.

Koen also is a Quality and Regulatory Affairs manager at Agfa Healthcare. His main expertise lies in clinical applications for general radiology, oncology, neurology, cardiology and orthopaedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps.

Combining a background in Risk Management and Electrical engineering gives Koen a unique insight into the regulatory world of software and healthcare apps.

  • Discuss the definitions of various software and apps including: standalone software, mobile applications, IVDs, active implantable
  • Analyse the regulatory requirements such as classification and PMS
  • Examine the criteria to determine whether your software is a device or not
  • Assess the various routes to market for a software/app when it is a device: CE marking, Notified Body, conformity assessment.
  • Assess the routes to market and alternative regulations when the software/app isn’t a device

This course is developed for those who are seeking to gain clarity on the regulations and requirements for software and apps developed for and used in healthcare, including:

  • Developers and Engineers
  • Regulatory Affairs Professionals

What is an Online Academy course? 

Online academy is an 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 4 weeks students will learn through:

  • 4 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
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 3 weeks the course is running
  • Additional content such as materials and white papers available to download

What happens during an Online Academy course?

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This online academy course can be accessed from 2nd July 2018. 1 module 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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