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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)"

18-21 November 2024 »
from £1999.00

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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

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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

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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.

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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.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

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

GBP 1,999
EUR 2,869
USD 3,269

4 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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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.

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 United Kingdom
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 United Kingdom
Embedded Software Engineer, Bedfont Scientific Ltd

Dec 11 2023

Extremely knowledgeable and capable presenters with very informative and well delivered content.

Derek Hoogerbrugge United Kingdom
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 Spain
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 United Kingdom
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 Switzerland
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 Spain
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 United Kingdom
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 Denmark
International Medical Manager, Novo Nordisk A/S

Oct 26 2021

Good course

Evie Eccles United Kingdom
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 Israel
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 Spain
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 United Kingdom
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 Netherlands
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 Switzerland
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 United Kingdom
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 Denmark
Regulatory Affairs Officer, Oticon A/S

Apr 29 2019

The course is well thought and based on the expert's experiences.

Ana Burman United Kingdom
Quality Engineer, Team Consulting

Apr 29 2019

Good

Arun Mahendran United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
Senior Regulatory Affairs Manager, GSK Consumer Healthcare

Nov 20 2018

One of the best training courses I have attended.

Ben Sadowyj United Kingdom
Senior Regulatory Assciate - Digital, RB Healthcare UK

Nov 20 2018

A very interesting and informative course. Excellent speakers

Laura Scatizzi Germany
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 Finland
Head of Compliance, Tieto Oyj

May 23 2018

Koen brought a lot of practical industry experience which was extremely useful.

Leon Doorn Netherlands
Sr. QA/RA Manager, Aidence B.V.

Nov 28 2017

A well structured, well presented programme

Peter Ogrodnik United Kingdom
Professor of Biomedical Engineering, Keele University

May 17 2017

Very good presentation

Massimo Panonzini Switzerland
Inpeco SA

Nov 28 2017

The speakers were knowledgable and interesting.

Cecile Boyer Switzerland
Senior Quality Project Manager, Novartis Pharma AG

Nov 28 2017

Good course. A lot of information in detail.

Jose Fernandez United Kingdom
Certification Manager, McLaren

May 17 2017

Excellent content - good choice of speakers

Malgorzata Wilinska United Kingdom
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 Belgium
Verification & Validation Officer, Ion Beam Applications SA

Nov 22 2016

Very good

Robert Gay Australia
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 Switzerland
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 United Kingdom
Associate Director Regulatory Affairs, UK, Teva UK Ltd

United Kingdom