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Navigating the Regulations for Health Apps and Medical Device Software

4-week online academy | 1 hour per week

4 March - 5 April 2019

Online Academy

Understanding the regulations regarding your medical device software or app is challenging with limited information available to developers. With the EU regulatory landscape changing, it is important to know which laws and regulations apply to your software to ensure optimal route to market. Intended as the first of three courses, 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. By the end of this course you will be able to navigate the EU regulations and identify which ones are relevant to your product.

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

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.

 

  • Determine whether your software or app is a medical device under the current definitions
  • Learn definitions of various software and apps including: standalone software, mobile applications, IVDs, active implantable
  • Familiarise yourself with the current classification system for medical devices, and know which class your software belongs in
  • Understand the EU Regulatory landscape, and know how to navigate these regulations and identify which ones are relevant to you
  • Assess the various routes to market for a software/app when it is a device: CE marking, Notified Body, conformity assessment.

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

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?

image mdti online academy websites infographic no title

This online academy course can be accessed from 4 March 2019. 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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