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.

26-29 Oct 2021 + 3 more dates

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  • Format: Live online, Classroom
  • CPD: 18 hours for your records
  • Certificate of completion

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.

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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The Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations 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 and case studies

  • 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
  • Manufacturer accountability
    • Risk management throughout the product life-cycle
    • Normal, abnormal and misuse
    • ESCs, SOUPs and COTs
    • Platform changes and failures
  • Risk communication considerations
  • Case studies/exercises

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

Practical construction of a clinical evaluation plan and report

  • What is it and what is included?
  • Who should write it?
  • How to write it
  • Tips & tricks

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

Koen Cobbaert works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys giving training and lectures and thrives on solving complex regulatory challenges.

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, New Technologies and Annex XVI devices 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). 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 delegated as Belgian expert to IEC JTC 1/SC 42 on artificial intelligence, ISO/TC 121/SC 3/JWG 12 on home respiratory equipment, ISO/TC215/JWG7 on health informatics, and to the IEC SC62A advisory group on software, networks and artificial intelligence.

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.

More details

Zuzanna Kwade

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.

More details

Book Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations Live online/Classroom training

26-29 Oct 2021

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11128

  • GBP 1,999
  • EUR 2,799
  • USD 3,118

Limited places remaining

In your basket 

25-28 Apr 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11907

  • GBP 1,599 1,999
  • EUR 2,239 2,799
  • USD 2,494 3,118

Until 21 Mar

In your basket 

4-7 Jul 2022

Classroom
London venue TBC

09:30-17:00 UK (London)
Course code 11418

  • GBP 1,999 2,399
  • EUR 2,799 3,359
  • USD 3,119 3,743

Until 30 May

  • 4 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

4-7 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11908

  • GBP 1,599 1,999
  • EUR 2,239 2,799
  • USD 2,494 3,118

Until 30 Aug

In your basket 

Reviews of IPI's Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations training course


The seminar was very good, the speakers and slides were very professionals and it covers wide aspects of the learned subjects.

Nov 17 2020

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 knowlegdable 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

UK

  • 3M
  • AstraZeneca
  • Babylon Partners Ltd
  • Bespak Europe Ltd
  • Biofortuna Ltd
  • Blackford
  • Bournemouth University
  • Bristows LLP
  • CGI IT UK Limited
  • CHIARA Regulatory Consultancy Services Ltd
  • ConvaTec
  • Crux Product Design
  • DCA Design International
  • DCA Design International Ltd
  • DSTL
  • Emis Ltd
  • GlaxoSmithKline (GSK)
  • GSK
  • GSK Consumer Healthcare
  • Hoffman LaRoche
  • Hospira, a Pfizer Company
  • Institute of Cancer Research
  • Ipsen
  • Ipsen Biopharm Ltd
  • Keele University
  • LumiraDx
  • McLaren
  • MED-EL Medical Electronics
  • 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
  • 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
  • Team Consulting
  • Technology Partnership Plc
  • Teva UK Ltd
  • The BBI Group
  • 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
  • Debiopharm International SA
  • DePuy Synthes
  • F. Hoffmann La Roche
  • F. Hoffmann-La Roche AG
  • GSK
  • Inovigate (Schweiz) GmbH
  • Inpeco SA
  • Medela AG
  • meditec Consulting GmbH
  • Novartis Pharma AG
  • Roche
  • Thoratec Switzerland GmbH

Denmark

  • 3Shape A/S
  • Agilent
  • Coloplast A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • 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

  • Dentsply Implants
  • IBA
  • Ion Beam Applications SA
  • MedTech Europe
  • Simmons & Simmons LLP
  • UCB BioPharma

Germany

  • Boehringer Ingelheim Corporate Center GmbH
  • Boehringer Ingelheim International GmbH
  • Covidien Deutschland GmbH
  • Fresenius Medical Care Deutschland GmbH
  • Merck Healthcare KGaA
  • Roche Diagnostics GmbH

Israel

  • Elcam Medical Ltd
  • NeuroDerm
  • Vectorious
  • Vectorious Medical Technologies

France

  • Guerbet
  • Medex by Guerbet
  • MEDEX Groupe Guerbet

Italy

  • Chiesi Farmaceutici S.p.a.
  • Orthofix Srl
  • Zirkonzahn GmbH

Australia

  • Cochlear
  • Cochlear Limited

Finland

  • Mobidiag
  • Tieto Oyj

Ireland

  • Boston Scientific
  • Teva Pharmaceuticals Ireland

Norway

  • Laerdal Medical AS
  • Lyfstone

Sweden

  • Mölnlycke Health Care AB
  • Wellspect Healthcare

Estonia

  • Estonian National Institute for Health Development

Korea, Republic Of

  • Yonsei University

Lithuania

  • Thermo Fisher Scientific Baltics

Luxembourg

  • Ordina Luxembourg SA

Poland

  • Genomtec SA

Saudi Arabia

  • Saudi Food and Drug Authority

Serbia

  • Medicines and Medical Devices Agency of Serbia

Spain

  • Clover Bioanalytical Software, Ltd

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Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy