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Medical Device Software: Complying with the MDR & FDA Regulations Training Course
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Details
Course overview
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
Why you should attend
- Learn how to qualify and classify software in Europe and the rest of the world
- Get in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22
- Understand the implications of the MDR and US Code of Federal Regulations for software
- Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software
- Learn how to write 510(k) and technical files
- Get a practical understanding of quality management, design control and how it applies to agile software development
- Hear the best practices on cyber security, risk management, usability andvalidation
- Learn the principles of clinical evaluations for software as a medical device
- Gain an insight into state-of-the-art standards applicable to software
Who should attend?
- Senior management and project leaders
- Software product managers, researchers, developers and clinical experts
- Software development process managers
- IT managers and integrators
- Internal and external auditors and/or consultants
- Regulatory affairs professionals
- Quality system and quality assurance personnel
- Technical and medical writers
- GUI designers
Presenter
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.
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28-30 Apr 2021 Live webinar |
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28-30 Apr 2021 Live webinar |
GBP 1,249.00 EUR 1,809.00 USD 2,056.00 Until 17 Mar 21* |
Enrol now
to attend Live webinar |
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5-7 May 2021 Face-to-face, (venue not yet confirmed) |
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5-7 May 2021 Face-to-face (venue not yet confirmed) |
GBP 1,549.00 EUR 2,169.00 USD 2,416.00 Until 24 Mar 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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27-29 Oct 2021 Live webinar |
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27-29 Oct 2021 Live webinar |
GBP 1,249.00 EUR 1,809.00 USD 2,056.00 Until 15 Sep 21* |
Enrol now
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 1,549.00 EUR 2,169.00 USD 2,416.00 Until 22 Sep 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
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Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
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Previous customers include...
- Bayer Consumer Care AG
- BioTop Medical
- Boehringer Ingelheim International GmbH
- Bournemouth University
- CHIARA Regulatory Consultancy Services Ltd
- Clover Bioanalytical Software, Ltd
- Covidien Deutschland GmbH
- Crux Product Design
- Debiopharm International SA
- Dentsply Implants
- DePuy Synthes
- Elcam Medical Ltd
- Emis Ltd
- Estonian National Institute for Health Development
- F. Hoffmann-La Roche AG
- Groupe Guerbet
- GSK Consumer Healthcare
- Hospira, a Pfizer Company
- Ipsen
- Laerdal Medical AS
- Medex by Guerbet
- Mirko Fortuna
- Nemaura Pharma
- Novartis Pharma AG
- Radiometer Medical ApS
- RDT Ltd
- Reckitt Benckiser Ld
- Technology Partnership Plc
- Teva UK Ltd
- Vectorious Medical Technologies
“Both very good and enthusiastic speakers. It is very nice that they work with MDSW and have a lot of examples, which makes it more understandable. I liked the course and learned a lot. ”
Jennie Mettivier Meijer, Project Manager Medical Devices & Quality Systems, BioTop Medical, Nov 19
“Both speakers were really good and brought the needed perspective to the discussion.”
Sandra Beltran Rodil, Associate Director, Regulatory Affairs, Teva UK Ltd, Apr 19
“Good”
Arun Mahendran, Regulatory Affairs Manager, Vision RT Limited, Apr 19
“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, Apr 19
“The course is well thought and based on the expert's experiences. ”
Ana Burman, Quality Engineer, Team Consulting, Apr 19
“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 , Apr 19
“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, Apr 19
“A very interesting and informative course. Excellent speakers”
Laura Scatizzi, Manager, Fresenius Medical Care Deutschland GmbH, Nov 18
“One of the best training courses I have attended.”
Ben Sadowyj, Senior Regulatory Assciate - Digital, RB Healthcare UK, Nov 18
“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, Nov 18
“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., Nov 18
“Big thank you to Koen! He shared the latest information of the risk classification guidance.”
Marika Miettinen, Head of Compliance, Tieto Oyj, Nov 18
“Koen brought a lot of practical industry experience which was extremely useful. ”
Leon Doorn, Sr. QA/RA Manager, Aidence B.V., May 18
“A well structured, well presented programme”
Peter Ogrodnik, Professor of Biomedical Engineering, Keele University, Nov 17
“Good course. A lot of information in detail.”
Jose Fernandez, Certification Manager, McLaren , Nov 17