An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
This intensive three-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The programme 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. Presentations will also offer practical tips on how to streamline the development process and provide an understanding of 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 addressed.
PLEASE NOTE DAY 3 CAN BE BOOKED AS A ONE DAY COURSE, PLEASE CONTACT US IF YOU WOULD LIKE TO TAKE THIS OPTION ON: info@management-forum.co.uk
- Symptoms and root causes of poor design control
- Waterfall vs Agile, iterative and spiral
- Principles of good design control
- Stage-gated model
- Project management
- Development planning
- Change management
- Requirements management
- Architecture & design
- Development
- Configuration management
- Verification & validation
- Defect management
- Design reviews
- IEC 62304 software life-cycle management
- IEC 82304-1 general requirements for product safety
- Management of software suppliers
- Critical suppliers
- Use of open source software
- Legacy software
Koen Cobbaert (More...)
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 (More...)
Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.
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 represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.
28-30 Apr 2021 Live webinar |
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28-30 Apr 2021 Live webinar |
GBP 1,549.00 EUR 2,229.00 USD 2,524.00 + VAT @ 20.00% |
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27-29 Oct 2021 Live webinar |
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27-29 Oct 2021 Live webinar |
GBP 1,549 1,249 EUR 2,229 1,809 USD 2,524 2,056 Until 15 Sep* |
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to attend Live webinar |
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3-5 Nov 2021 Face-to-face, (venue not yet confirmed) |
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3-5 Nov 2021 Face-to-face (venue not yet confirmed) |
GBP 1,849 1,549 EUR 2,589 2,169 USD 2,884 2,416 Until 22 Sep* |
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to attend Face-to-face (venue not yet confirmed) |
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