Presented by
Management Forum
Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations In-house Training
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 (37)"
- Format: Live online
- CPD: 30 hours for your records
- Certificate of completion
You may also be interested in...
- 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
Course overview
Master the critical decisions that shape your software’s regulatory success. Every choice you make, from product claims to technology selection and regulatory positioning, can determine the outcome of your market authorisation process. Missteps can mean costly delays, increased development expenses and even denied market entry. This course gives you the clarity and confidence to avoid these pitfalls and ensure your innovation achieves its full global potential.
With emerging technologies such as digital therapeutics, machine learning and cloud computing, navigating the regulatory landscape has never been more complex. Distinguishing medical from non-medical software, defining clinical validation needs, understanding international regulatory differences and meeting diverse market authorisation requirements are just some of the challenges you will tackle.
This course offers a clear, practical understanding of global medical device software regulations. Through expert-led sessions, hands-on exercises and real-world case studies, you will gain the insights and skills needed to confidently steer your software through regulatory pathways and bring it successfully to market.
You will also explore best practices for developing and managing regulated software and learn how to implement them effectively without stifling innovation. Discover how to balance flexibility in the early stages of design with the rigorous oversight needed to deliver a final build that is safe, reliable and fully compliant. This nuanced approach is difficult to master without practical experience and informed guidance, and that is exactly what this course provides.
Led by industry experts with extensive hands-on experience, you will leave equipped with the strategies and knowledge to transform your development process and ensure your products meet the highest standards of quality and safety.
Don’t miss this opportunity to strengthen your expertise and drive successful medical device software projects. Register today to secure your place.
This course is part of our range of Medical Devices training courses
Benefits of attending
- Examine the borderline between general health and wellness, medical and pharmaceutical software with confidence
- Master the criteria that qualify software as a medical device and avoid regulatory missteps
- Understand how claim and technology decisions are tied to market authorisation obligations
- Identify the pros and cons of splitting your software into platforms and modules
- Expand your understanding of EU and US market authorisation processes and obligations for software products
- Find out how to define and generate sufficient clinical evidence to bring and keep your software on the market
- Get to grips with configurable devices, accessories, systems and parts, and how strategic use can ease your administrative burden
- Learn best practices for compliant software development and management while keeping bureaucracy under control
- Examine essential techniques to boost product quality and maintain business continuity amid staff changes and evolving IT environments
Who should attend
- Product & Strategy
- Business strategists
- Product managers
- Service and sales managers
- Regulatory, Legal & Quality
- Regulatory affairs specialists and managers
- Legal professionals
- Compliance officers
- Quality assurance engineers
- Engineering, Development & Validation
- Software developers
- System analysts
- Technical writers
- Biomedical engineers
- Clinical validation specialists
- Usability engineers
- Risk management moderators
- Project & Clinical Leadership
- Project managers
- Clinical informatics managers
- Clinical research associates
- R&D engineers
This course covers the foundational principles that apply across all software techniques. For those interested in delving deeper into artificial intelligence, machine learning, and generative AI, we offer the Masterclass: Market Authorisation of AI-enabled Medical Devices. Designed as a natural adjunct to this course, the masterclass builds on the concepts introduced here and explores their practical application in AI-driven healthcare solutions.
This course will cover:
Welcome - introduction to the regulations
- Exploratory exercise to discover the borderline between medical device, pharmaceutical, and cosmetic regulation through a case study
Is it a medical device, or not?
- Medical device and in vitro diagnostic device definitions, their terminology, and software considerations
- Intended purpose and claim specificity
- Borderline between medical device software and lifestyle and fitness software
Software qualification
- Modules and software with multiple functions
- Functional exemptions
- Population health and educational software
- Search engines, Q&A tools, and chatbots
- Resource and workflow management software
- Clinical decision software
International comparison
- Software as a Medical Device (SaMD) according to the IMDRF
- SaMD ≠ Medical Device Software
- IMDRF SaMD risk stratification framework and its pitfalls
- International differences (US, Canada, South Korea, …)
Case studies on qualification
Considerations for placement on the market
- Placing and making available on the market
- Subscription models, cloud computing, and software as a service
- Pros and cons of the modular approach
- Software platforms
- Software accessories, systems, components
- Legal status of wearables
Case study on regulatory positioning
Case study on wearables
Borderline with medicine legislation
- Companion diagnostics, medication management, and adherence apps
- Digital therapeutics
- Borderline with pharmaceuticals, combination products
Case study on borderline with medicine legislation
EU market authorisation of medical device software
- Overview of EU market authorisation process
- Engaging with a Notified Body
- UDI versus Basic UDI
- EUDAMED
- Declaration of Conformity
- Person Responsible for Regulatory Compliance
- Authorized representatives
- Economic operators: distributors, importers, and service fulfilment centres
- App Stores and Digital Distribution Platforms
- Software traceability
- Monitoring critical components or platform updates
- Software recalls
- Unannounced Notified Body Audits
- Service updates, upgrades, and other changes
Case study on software distribution
Case study: a great idea for a start-up!
General Safety and Performance Requirements for software
- Harmonised standards
- Common specifications
- GSPR Checklist
- Software labelling
- Use of language and symbols
- IT environment and mobile platforms
- Repeatability and reliability of machine learning software
- Instructions for use
Practical Construction of a Technical file
- Content
- Example
US Market authorisation (FDA)
- US Code of Federal Regulations and its Implications for Software
- 510(k) process and de novo process
- FDA Guidance’s specific to software
- FDA expectations for machine learning software
Case study on US market authorization
Discussion – International go-to-market considerations
Classification of Medical Device Software
- Implementing Rules
- Classification rules
- Software that drives or influences the use of a (hardware) medical device
- Classification Rule 11
- IMDRF SaMD risk type determination
- IMDRF SaMD risk stratification framework and its pitfalls
- Classification Rules 13, 15, and 22
Case studies – Classification
Borderline cases
- Borderline manual on qualification and classification
- Helsinki procedure
- Dispute resolution and fair competition
Software Development Models
- Symptoms and root causes of poor design control
- Waterfall vs Agile, iterative, and spiral development
- Principles of good design control
- Stage-gated models
Best practices to manage design activities
- Project Management
- Development Planning
- Change Management
- Requirements Management
- Architecture & Design
- Development
- Configuration Management
- Verification & Validation
- Defect Management
- Design Reviews
State-of-the-art standards for regulatory compliance
Software Development Standards for regulatory compliance
- IEC 62304 Software Lifecycle Management
- IEC 82304-1 General Requirements for Product Safety
Managing software suppliers and subcontractors
- Managing software suppliers
- Outsourcing design activities
- Identifying critical suppliers
- Managing software platforms and plugins
- Using open-source software
- Using legacy software
Software usability
- Managing the human element of risk
- Designing for happiness
- Terminology, Roles and Responsibilities
- Human factors Engineering
- User Experience Design (UXD)
- Process
User experience evaluation 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
- US FDA requirements
- IEC 62366-1, etc.
- Usability guides
Safety Risk Management
- Process, terminology, roles
- Risk Identification Methodologies
- Checklists
- Grey Box
- Hazard and Operability Analysis (HAZOP)
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTE)
Risk Control
- Risk reduction paradigms
- Risk reduction under single fault condition
- Inherently safe design
- Preventive measures
- Corrective measures
- Mitigations
- Safety notices
- Disclosures of residual risk
- Risk control strategies
Case study on risk identification
Risk assessment & evaluation
- IMDRF terminology
- Determining severity and probability of harm
- Determining if a risk is acceptable
- Benefit-risk assessment
- Risk Management Deliverables
Risk management throughout the product lifecycle
- Risk management throughout the product lifecycle
- Risk management of ESCs, SOUPs, COTS and platforms
Risk perception and communication
- Involving external stakeholders in assessing risk
- Communication in times of crisis
Core concepts in clinical evaluation of medical software
- The regulatory framework of gathering clinical evidence for devices. International differences (EU, US, UK, …)
- Clinical evaluation during software lifecycle
- Clinical vs performance evaluation
- Direct and indirect benefits and risks
Setting the right scope and level of evidence for medical software
- Validation of clinical association, technical performance and clinical performance
- Role of the standards and scientific literature
- Considerations for AI/ML-based devices
The literature review process
Case Studies – clinical evaluation of medical device software
Assessing and documenting clinical evidence: The Clinical Evaluation Report
Clinical and performance studies
- When is a clinical investigation needed for medical device software
- Selecting appropriate study design
- Application of standards
- Clinical performance studies
- Regulatory and ethical considerations
Post-Market Surveillance and Post-Market Clinical Follow up
- Post-market regulatory requirements
- The role of Real-World data and Real-World Evidence
- Implementing Post-Market Clinical Follow-up for medical device software
- Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance
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
Nov 18 2024
[Speakers had] huge expertises. I accomplished what I wanted to achieve from this course.
Wicem Boumalouka 
Chef de Projet, Guerbet LLC
Nov 18 2024
It was really good, both speakers tried to keep the audience attention with interactive tasks. As an overall view I am satisfied with the webinar and with the provided training materials, both with the shared information and the information quality.
Szilvia Schmidt 
AMD Technical Specilaist, B.Braun Medical Hungary Ltd
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
- ISO Sense Consulting 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
- Ability Neurotech
- 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
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
Austria
- B.Braun Medical Hungary Ltd
- MED-EL
Finland
- Mobidiag
- Tieto Oyj
Norway
- Laerdal Medical AS
- Lyfstone
Sweden
- Mölnlycke Health Care AB
- Wellspect Healthcare
Estonia
- Estonian National Institute for Health Development
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
5 days
Typical duration
Pricing from:
- GBP 1,875
- 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:
