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Applying The Regulations: Creating Safe & Secure Health Apps & Medical Device Software

Apply the latest EU regulations to your health app or software

1 - 19 April 2019

Online Academy

Are you aware of the methodologies available to identify and manage risk associated with your software?

Health software qualifying as a medical device must comply with the general safety and performance requirements (GSPR) pertaining to safety and security. Intended as a follow-on from ‘Navigating the Regulations’, this course teaches you best-practices to apply EU safety and security regulations ensuring your device is compliant, maximising user safety and security. By means of industry expertise and practical examples, this course outlines methodologies such as Hazard and Operability Analysis (HAZOP) and Failure Modes Effects Analysis (FMEA) to adequately identify and manage risks associated with security and safety ensuring the design of safe and secure health software.

Koen Cobbaert

Koen Cobbaert represents COCIR in numerous work groups at European level. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries. In 2009 COCIR created its software task force, which Koen has been chairing ever since. He put on paper the first draft of the qualification decision tree, which was later successfully adopted by the Member States in “MEDDEV 2.1/6 on the qualification and classification of standalone software”.

Under Koen’s leadership COCIR’s software task force has contributed to the 1st and 2nd edition of this MEDDEV and has proposed the IMDRF work item on software as a medical device, which ultimately lead to IMDRF guidance on the qualification, risk stratification and clinical evaluation of software as a medical device. Currently Koen’s work focuses on drafting the European guidance for classification of medical device software, which is expected to clarify among others the use of classification rule 10 and 11 under the Medical Device Regulation (MDR).

Koen Cobbaert wrote several COCIR papers on a variety of software-related topics under the MDR: qualification of and responsibilities for rules engines, programming and runtime environments and libraries for dataflow programming and machine learning, economic operator requirements for app stores and digital marketplaces, significant changes of software, UDI numbers, etc.

Via COCIR’s standards focus group Koen Cobbaert contributed to the development of IEC 82304 on safety requirements for health software and IEC 62304 on software lifecycle processes. Koen co-authored the FAQ on IEC 62304, which has been translated in several languages. Via COCIR’s North American sister organisation MITA Koen also contributed to several FDA guidance papers, including the guidance papers on patient and clinical decision support systems and on computer-assisted detection devices applied to radiology images and radiology device data.

Koen Cobbaert has over 15 years of hands-on experience in establishing regulatory strategies, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software 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.

Koen Cobbaert has a Master in Risk Management and Electrical Engineering
Currently Koen Cobbaert works for Philips Healthcare as quality and regulatory manager.

  • Understand the importance of cybersecurity for health apps by learning about the key principles of data integrity
  • Learn to minimise safety and security risks by applying methodologies detailed under GSPR
  • Understand key risk management strategies to adequately identify safety and security risks associated with your software
  • Develop your project management techniques to maximise the efficiency of your daily processes

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

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 3 weeks students will learn through:

  • 3 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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One 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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