This course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The seminar will be highly interactive, using real-life examples and state- of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation. In addition, there will be practical tips on how to streamline the development process, understand the regulatory requirements and how Notified Bodies review technical files.
There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard and advice on how to validate your system design will also be covered.
Medical device software qualification and classification
Software classification – EU
Classification according to the FDA
Bringing medical device software on the EU market
Notified Bodies and the evidence they consider
Practical construction of a technical file
EUDAMED registration and distribution chain responsibilities
On the market
Bringing medical software on the US market
Rest of the world (Brazil, Canada etc.)
Standards and their implementation – a software perspective
Fundamental principles design control
Design activities in detail
Peter Pringle is a consultant with international hospital experience; he has managed projects in installation, process and software. His medical software experience brings a unique understanding of the quality systems and configuration control that is required to make a project right first time. He has the ability to focus and create a vision, interact and motivate at all levels while not afraid of confrontation and accepting responsibilities. He enjoys the challenge of empowering people to be accountable for their tasks bringing about the ability to see the big picture in a very short space of time. Since May 2000 he has operated as an independent (Accredited Business Link & MHRA) consultant. He has established an expertise in developing project proposals and stimulating co-maker and e-business relationships with many companies, also developing and submitting major project proposals for several clients with considerable success. From 1986 to 2000 he worked in the Radiotherapy division of Philips Medical Systems (purchased by Elekta of Sweden) whose main products consist of a range of computer controlled linear accelerators for the treatment of cancer.
He has worked extensively in Scandinavia, Germany, Italy, Russia, USA and Great Britain. With this experience he can bring a very personal view of project processes, interpretation and implementation to any forum, together with a unique ability to focus a team on the objectives and goals that are required by the sponsor of the project.
Peter is qualified in ISO 13485 / 9000 / 14000 / 14971 and prepares FDA pre audits, establishing technical documentation for product compliance to the Medical Device Directive, he also advises companies on software development procedures and documentation.
Koen Cobbaert is quality and regulatory manager at Philips Healthcare. He 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 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 he 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 he 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 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. He has a Master in Risk Management and Electrical Engineering.
Zuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represents COCIR in the European Union Task Force on clinical evaluation of software.