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.
To build reliable and trustworthy software you should nevertheless use state-of-the-art techniques and best practices. This course will equip you with a working knowledge of the technical vocabulary and processes needed to make software that is both safe and secure.
Along this journey you will learn the safety and performance requirements imposed by law on medical device manufacturers. You will learn what evidence you need to collect, what legal requirements you need to consider and how you must compile a technical file that enables you to perform a successful regulatory submission. Case studies will show you tips and tricks, but also warn you for the pitfalls you may encounter.
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.
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:
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.
Once you have registered and made the full payment, you will be given login details to access the course.
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.