Health Apps and Medical Device Software in Europe

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”.

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 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.

Zuzanna Kwade

Zuzanna Kwade is clinical post-market surveillance team lead at Agfa Healthcare. She is an active member of COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries and represents COCIR in clinical evaluation of software task force at European level. Zuzanna has over 10 years of hands-on experience in clinical safety management in pharma and medical device studies. She holds a PhD in molecular biology.

• Gain a comprehensive overview of the EU regulatory framework for software products
• Understand the safety and performance requirements imposed by law on medical device manufacturers
• Become equipped with a working knowledge of the technical vocabulary and processes needed to make safe, secure, reliable and effective software
• Learn what evidence to collect and how to compile a technical file and clinical evaluation report
• Critically analyse how neural networks, machine learning, and autonomous systems challenge classical safety processes and principles
• The course is complemented by case studies, practical sessions and quizzes

The course covers software-only products, hardware product with embedded software, health apps and medical device software and is suitable for professionals in the following roles:

• Project and Product Management
• Software Architects
• Designers and Developers
• Research & Development Management
• Requirements Engineers
• Verification, Validation and Clinical Evaluation Specialists
• Usability Experts
• Cybersecurity Experts
• Risk Management Moderators
• Quality and Regulatory Specialists