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Navigating the Regulations for Health Apps and Medical Device Software

4-week online academy | 1 hour per week

4 - 29 November 2019

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.

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

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.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

 

Watch the Online Academy Video

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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