Presented by
Management Forum
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
★★★★★ "Both speakers extremally knowledgeable and fantastic teachers. thoroughly enjoyed the course! Fantas... more (35)"
18-21 November 2024 »
from £1999.00
This intensive four-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.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.
In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).
In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).
Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
18-21 November 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14069
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Both speakers extremally knowledgeable and fantastic teachers. thoroughly enjoyed the course! Fantastic all around!
Jul 22 2024
Neisha Kearney
Quality Associate, Axial
Apr 24 2023
A lot of information covered areas outside of scope of work but I found it very informative and gave me a good understanding of the entire lifecycle of a medical device.
Steve Casey
Embedded Software Engineer, Bedfont Scientific Ltd
Dec 11 2023
Extremely knowledgeable and capable presenters with very informative and well delivered content.
Derek Hoogerbrugge
Accenture UK Ltd
Oct 17 2022
Fantastic course. Speakers were quite knowledgeable and were able to transmit the information in a great way. They were willing to answer all of our questions/doubts at any time during the webinar. I found the MD Classification of particular interest.
Samuel Pelaez Machado
Software Lead, Neuroelectrics Barcelona, S.L.U.
Oct 17 2022
This course contained excellent content and speakers. I enjoyed that it was interactive with case studies and quiz exercises to keep engagement up and check understanding.
Janine Barnard
Regulatory Affairs Specialist, Perspectum
Oct 17 2022
Very good webinar in term of content, presentation and speakers. Lots of extra material made available by the presenters
Didier Gasser
Senior Project Manager, Helbling Technik Bern AG
Oct 17 2022
Overall I am satisfied. Well organized and good quality of speakers and materials
Conxi Verdú
RA & QA Director, Neuroelectrics Barcelona, S.L.U.
Apr 25 2022
I wanted to learn the nuance of software as a medical device to support my role as a quality engineer for IVD's. I do feel more equipped now to provide recommendations to colleagues and perform my role effectively. The presenters did a great job of keeping the audience engaged through virtual presentations. The breakout rooms and polls were a good opportunity to consider what we'd learnt. It was a very good course, the content was really helpful.
Louise Richards
Quality Director, SPD Development Company Ltd
Oct 26 2021
The course covered a vast area, and it was helpful to follow new requirements/changes.
Jitendra Gupta
International Medical Manager, Novo Nordisk A/S
Oct 26 2021
Good course
Evie Eccles
Quality Assurance and Regulatory Compliance Manager, Blackford
Nov 17 2020
The seminar was very good, the speakers and slides were very professionals and it covers wide aspects of the learned subjects.
Avital Levertov
Regulatory Affairs Manager, Elcam Medical Ltd
Nov 17 2020
I think it has been very useful and interesting, and I believe most people has been involved and participating, which makes it lively and helps you keep in the flow when doing online training.
Luis Mancera Pascual
Executive Director, Clover Bioanalytical Software, Ltd
Nov 17 2020
I enjoyed the webinar very much, both presenters were very good and showed their depth of knowledge.
Sabrina Solomon
Safety Scientist, Ipsen
Nov 20 2019
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
Apr 29 2019
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 29 2019
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 29 2019
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 29 2019
The course is well thought and based on the expert's experiences.
Ana Burman
Quality Engineer, Team Consulting
Apr 29 2019
Good
Arun Mahendran
Regulatory Affairs Manager, Vision RT Limited
Apr 29 2019
Both speakers were really good and brought the needed perspective to the discussion.
Sandra Beltran Rodil
Associate Director, Regulatory Affairs, Teva UK Ltd
Nov 20 2018
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 20 2018
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 20 2018
One of the best training courses I have attended.
Ben Sadowyj
Senior Regulatory Assciate - Digital, RB Healthcare UK
Nov 20 2018
A very interesting and informative course. Excellent speakers
Laura Scatizzi
Manager, Fresenius Medical Care Deutschland GmbH
Nov 20 2018
Big thank you to Koen! He shared the latest information of the risk classification guidance.
Marika Miettinen
Head of Compliance, Tieto Oyj
May 23 2018
Koen brought a lot of practical industry experience which was extremely useful.
Leon Doorn
Sr. QA/RA Manager, Aidence B.V.
Nov 28 2017
A well structured, well presented programme
Peter Ogrodnik
Professor of Biomedical Engineering, Keele University
May 17 2017
Very good presentation
Massimo Panonzini
Inpeco SA
Nov 28 2017
The speakers were knowledgable and interesting.
Cecile Boyer
Senior Quality Project Manager, Novartis Pharma AG
Nov 28 2017
Good course. A lot of information in detail.
Jose Fernandez
Certification Manager, McLaren
May 17 2017
Excellent content - good choice of speakers
Malgorzata Wilinska
Research Associate, University of Cambridge
May 17 2017
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
Nov 22 2016
Very good
Robert Gay
Senior Regulatory Affairs Manager - External Products and Software, Cochlear Limited
Apr 26 2016
Very good, I would recommend this course for beginners and advanced levels
Arnaud Biermann
Senior Manager Regulatory Affairs, Anteis SA
Apr 26 2016
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
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3 days
Typical duration
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We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: