An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
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.
Introduction to the regulations
Software qualification
Software classification
General principles to bring medical device software to the EU market
Introduction to General Safety and Performance Requirements (GSPR)
Interpretation of GSPR and their implications for software
Technical file
General principles to bring medical device software to the US market
Practical construction of a 510(k)
Go-to-market strategy
Software development models
Design activities
Software development standards
Safety and essential performance of electrical medical equipment IEC 60601 and Appendix H
Security risk management
IEC 80001: Application of risk management to IT-networks incorporating medical devices
Safety risk management
Usability of medical devices
Clinical evaluations of medical device software
Practical construction of a clinical evaluation plan and report
Introduction to clinical investigations
Post-market surveillance (PMS)
Process interfaces
Koen Cobbaert
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
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.
| 20-22 Nov 2019 | |||
| 20-22 Nov 2019 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Registration for this event now closed. |
| 28-30 Apr 2020 | |||
| 28-30 Apr 2020 | Holiday Inn London - Kensington Forum, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 17-19 Nov 2020 | |||
| 17-19 Nov 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
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“Good course, very interesting and complete overview with speakers that bring the insights of both an ex-auditor and an industry representative. ”
Antoine Nguyen, Associate Regulatory Program Manager , Roche
“Both speakers were really good and brought the needed perspective to the discussion.”
Sandra Beltran Rodil, Senior Manager Regulatory Affairs, Teva UK Ltd
“A very worthwhile introduction to the regulatory requirements of medical device software for anyone new to this device type. The course covered a broad range of relevant subjects and was delivered by speakers who were clearly highly experienced but also passionate about the subject matter. I would definitely recommend! ”
Suzanne Morgan, Group Head of Regulatory Affairs, The BBI Group
“Good”
Arun Mahendran, Regulatory Affairs Manager, Vision RT Limited
“The course is well thought and based on the expert's experiences. ”
Ana Burman, Quality Engineer, Team Consulting
“A good intensive course - I would recommend for my colleagues especially who need a general understanding of MDR impact on medical SW. ”
Camilla Inesa Cernajute, Regulatory Affairs Officer, Oticon A/S
“One of the best training courses I have attended.”
Ben Sadowyj, Senior Regulatory Assciate - Digital, RB Healthcare UK
“This is one of the best training organised by Management Forum in term of the quality of the content and presenters. I am equipped to do my job! ”
Cadence Tan, Senior Regulatory Affairs Manager, GSK Consumer Healthcare
“Engaging delivery of the subject by speakers who clearly had extensive knowledge and experience of medical device software in a regulatory environment.”
Stephen Matthews, Validation Consultant, Smart Process Solutions Ltd.
“Big thank you to Koen! He shared the latest information of the risk classification guidance.”
Marika Miettinen, Head of Compliance, Tieto Finland oy
“A very interesting and informative course. Excellent speakers”
Laura Scatizzi, Manager, Fresenius Medical Care Deutschland GmbH
“Koen brought a lot of practical industry experience which was extremely useful. ”
Leon Doorn, Sr. QA/RA Manager, Aidence B.V.
“The speakers were knowlegdable and interesting. ”
Cecile Boyer, Senior Quality Project Manager, Novartis Pharma AG
“Good course. A lot of information in detail.”
Jose Fernandez, Certification Manager, McLaren
“A well structured, well presented programme”
Peter Ogrodnik, Professor of Biomedical Engineering, Keele University
“Very good presentation”
Massimo Panonzini, Inpeco SA
“Excellent content - good choice of speakers”
Malgorzata Wilinska, Research Associate, University of Cambridge
“It was great that both speakers had an understanding of what devices IBA makes and they tried to give suitable answers for our case”
Inez Wathion, Verification & Validation Officer, Ion Beam Applications SA
“Very good”
Robert Gay, Senior Regulatory Affairs Manager - External Products and Software, Cochlear Limited
“Very good, I would recommend this course for beginners and advanced levels”
Arnaud Biermann, Senior Manager Regulatory Affairs, Anteis SA
“The presentations in the folders did not follow the order that was presented by the speakers. Always best to check beforehand with the speakers the order of information as ideally it should match of presentation. This meant we were all looking for the slides whilst the speakers had started, meaning we often missed some important points.”
Priti Darjee, Associate Director Regulatory Affairs, UK, Teva UK Ltd