Presented by
Management Forum
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
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)"
- Format: Live online
- CPD: 24 hours for your records
- Certificate of completion
- Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
- Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
- Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
- Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
- Data Innovation for AI-enabled Medical Devices
- Masterclass: Market Authorisation of AI-enabled Medical Devices
- Masterclass: Artificial Intelligence-based Medical Devices
Course overview
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.
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
This course will cover:
Introduction to the regulations
Software qualification – is it a medical device or not?
- Medical device definitions
- In-vitro diagnostic software
- Multi-functionality software
- Cloud computing and software as a service
- Intended purpose
- Excluded functionality
- Borderline with lifestyle and fitness software
- Borderline with pharmaceuticals, combination products
- Companion diagnostics, medication management and adherence apps
- Population health and educational software
- Resource and workflow management vs clinical decision support software
- Clinical decision software
Considerations for placement on the market
- International comparisons-qualification differences (US, Canada, Brazi,…)
- Pitfalls with the interpretation of the IMDRF SaMD risk framework
- Pros and cons of the modular approach
- software platforms
- Software accessories, systems components
- Legal status of wearables
Case studies – qualification
Software classification
- Implementing rules
- Software that drives or influences the use of a (hardware) medical
device - Classification rules, including classification rule 11
- IMDRF SaMD risk type determination
Case studies – classification
MDR in a nutshell with software considerations
- Go to market process
- Engaging with a Notified Body
- Controlling software suppliers and subcontractors
- UDI number
- EUDAMED
- Declaration of Conformity
- Person responsible for regulatory compliance
- Software traceability
- Distributors, importers, authorised representatives and their liability
- App stores and digital distribution platforms
- Software recalls
- Unannounced Notified Body audits
- Service updates, upgrades and other changes
Case study: a great idea!
Safety and performance requirements for software
- Harmonised standards
- Common specifications
- GSPR checklist
- Software labelling
- IT environment and mobile platforms
- Repeatability and reliability of machine learning software
- Software labeling
- Instructions for use
Practical construction of a technical file
- Content
- Example
Placing medical device software on the US market
- US Code of Federal Regulations and its' implications for software
- 510(k) process
- FDA Guidances specific for software
- FDA expectations for machine learning software
Practical construction of a 510(k)
International go-to-market considerations
- Challenges faced for app developers to have their app taken up in care pathways
- Quality and reliability of health and wellness apps
- Evolving policy and reimbursement landscapes for digital health technologies
- Quality and reliability of health and wellness apps
Controlled design of health software
- Software development models
- Symptoms and root causes of poor design control
- Waterfall vs Agile, iterative and spiral
- Principles of good design control
- Stage-gated model
- Design activities
- Project management
- Development planning
- Change management
- Requirements management
- Architecture & design
- Development
- Configuration management
- Verification & validation
- Defect management
- Design reviews
- Software development standards
- IEC 62304 software life-cycle management
- IEC 82304-1 general requirements for product safety
- Outsourcing
- Management of software suppliers
- Critical suppliers
- Software platforms and plugins
- Use of open source software
- Legacy software
Software usability
- Managing the human element of risk
- Designing for happiness
- Terminology, roles and responsibilities
- Use Experience Design (UXD)
- Process and techniques
- Formative evaluation
- User observations
- Walkthroughs
- Heuristic review
- Key-stroke level model
- Summative evaluation
- Product reaction cards / word association
- Single Ease Question (SEQ)
- System Usability Score (SUS)
- Interface with risk management
- Regulatory requirements and standards
- EU MDR/IVDR requirements
- USA FDA requirements
- IEC 62366-1, etc.
- Usability guides
Safety risk management – ISO 14971
- Process, terminology, roles
- Risk Identification Methodologies
- Checklists
- Grey box
- Hazard and Operability Analysis (HAZOP)
- Failure Modes and Effects Anaylsis (FMEA)
- Fault Tree Analysis (FTE)
- Risk Control
- Inherently safe design
- Preventive measures
- Corrective measures
- Mitigations
- Safety notices
- Disclosures of residual risk
- Risk control strategies
- Risk assessment and evaluation
- IMDRF terminology
- Determining severity and probability of harm
- Determining if a risk is acceptable
- Benefit-risk assessment
- Deliverables
- Other risk management aspects
- Risk management throughout the product life-cycle
- Risk management of ESCs, SOUPs, COTS and platforms
- Risk perception and communication
Clinical evaluations
- Definitions, purpose, deliverables
- Process and key characteristics
- Selecting data sources
- Defining a scope and a sufficient level of clinical evidence for medical device software
- Role of validation and usability
- Considerations for artificial intelligence and continuous learning software
Development of a literature review protocol
- Selecting databases and conducting searches
- Defining search strategy
Case studies – clinical evaluation of medical device software
Clinical investigations and performance studies
- General principles of clinical investigations
- When is a clinical investigation needed for medical device software
- Selecting appropriate study design
- Application of standards
- Clinical performance studies
- Generating evidence of effectiveness
- Challenges of health trials
- Reporting
- Regulatory and ethical considerations
Post-Market Surveillance and Post-Market Clinical Follow up
- Post-market regulatory requirements
- Components of an effective PMS
- Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting
- Implementation of Post Market Clinical Follow-up for medical device software
- Real-World Evidence
- Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance to streamline ways of working
Koen Cobbaert
Philips Healthcare
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
Dedalus Healthcare
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.
Reviews of IPI's Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations training course
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
United Kingdom
- 3M
- 42 Technology Ltd
- Accenture UK Ltd
- AstraZeneca
- Axial
- Babylon Partners Ltd
- Bedfont Scientific Ltd
- Bespak Europe Ltd
- Biofortuna Ltd
- Blackford
- Bournemouth University
- Bristows LLP
- CGI IT UK Limited
- CHIARA Regulatory Consultancy Services Ltd
- ConvaTec
- Corin Limited
- Crux Product Design
- DCA Design International
- DCA Design International Ltd
- DSTL
- Emis Ltd
- Freyr Life science
- GlaxoSmithKline (GSK)
- GSK
- GSK Consumer Healthcare
- Haag Streit
- Hoffman LaRoche
- Hospira, a Pfizer Company
- Institute of Cancer Research
- Ipsen
- Ipsen Biopharm Ltd
- Keele University
- LumiraDx
- McLaren
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Mundipharma R&D Ltd
- Nemaura Pharma
- Okko Health
- PA Consluting
- PA Consulting
- PA Consulting Group
- Perspectum
- Perspectum Diagnostics
- Pfizer Limited
- Pfizer Ltd
- Prothea Technologies Ltd.
- Psephos Ltd
- Quanta Dialysis Technologies
- RB
- RB Healthcare UK
- Reckitt Benckiser Ld
- Remote Diagnostic Technologies Ltd.
- RQRA
- SGR Consulting Services Ltd
- Smart Process Solutions Ltd.
- SPD Development Company Limited
- SPD Development Company Ltd
- Team Consulting
- Technology Partnership Plc
- Teva UK Ltd
- The BBI Group
- The University of Manchester
- Toshiba Medical Visualization Systems
- UCB
- University of Cambridge
- Vision RT Limited
- Waters-Micromass
Switzerland
- Anteis SA
- ARES Trading SA
- Ascensia Diabetes Care Holdings AG
- Bayer
- BD Switzerland
- Cochlear AG
- Debiopharm International SA
- DePuy Synthes
- F. Hoffmann La Roche
- F. Hoffmann-La Roche AG
- GSK
- Helbling Technik Bern AG
- Inovigate (Schweiz) GmbH
- Inpeco SA
- Medela AG
- meditec Consulting GmbH
- Novartis Pharma AG
- Roche
- Thoratec Switzerland GmbH
- Wyss Center
Denmark
- 3Shape A/S
- Agilent
- Ambu A/S
- Coloplast A/S
- Novo Nordisk A/S
- Novo Nordisk AS
- Oticon
- Oticon A/S
- Radiometer Denmark
- Radiometer Medical ApS
Netherlands
- Aidence B.V.
- Aidence BV
- BioTop Medical
- Omron Healthcare
- Omron Healthcare Europe BV
- Teledyne DALASA
- Teledyne DALSA
- TomTom International B.V.
Belgium
- Agilent Technologies
- Dentsply Implants
- IBA
- Ion Beam Applications SA
- MedTech Europe
- Simmons & Simmons LLP
- UCB BioPharma
Germany
- Boehringer Ingelheim Corporate Center GmbH
- Boehringer Ingelheim International GmbH
- CONSILIO ET OPERA GMBH
- Covidien Deutschland GmbH
- Fresenius Medical Care Deutschland GmbH
- Merck Healthcare KGaA
- Roche Diagnostics GmbH
France
- Guerbet
- Guerbet LLC
- Medex by Guerbet
- MEDEX Groupe Guerbet
- Owkin
Israel
- Align Technology
- Elcam Medical Ltd
- NeuroDerm
- Vectorious
- Vectorious Medical Technologies
United States of America
- Abbott - Mark Determan
- Bristol Myers Squibb
- Bristol Myers Squibb Company
- GSK
- Haemonetics (UK) Ltd
Spain
- Clover Bioanalytical Software, Ltd
- Consultys
- Neuroelectrics
- Neuroelectrics Barcelona, S.L.U.
Ireland
- Abbott
- Boston Scientific
- Teva Pharmaceuticals Ireland
Italy
- Chiesi Farmaceutici S.p.a.
- Orthofix Srl
- Zirkonzahn GmbH
Korea, Republic Of
- AJOU University
- Dongguk univ.
- Yonsei University
Poland
- EPAM Systems (Poland) Sp.z o.o
- Eurofins GSC IT PL
- Genomtec SA
Australia
- Cochlear
- Cochlear Limited
Finland
- Mobidiag
- Tieto Oyj
Norway
- Laerdal Medical AS
- Lyfstone
Sweden
- Mölnlycke Health Care AB
- Wellspect Healthcare
Austria
- MED-EL
Estonia
- Estonian National Institute for Health Development
Hungary
- B.Braun Medical Hungary Ltd
Lithuania
- Thermo Fisher Scientific Baltics
Luxembourg
- Ordina Luxembourg SA
Saudi Arabia
- Saudi Food and Drug Authority
Serbia
- Medicines and Medical Devices Agency of Serbia
Run Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations Live online for your team
3 days
Typical duration
Pricing from:
- GBP 1,200
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
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:
