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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.

★★★★★ "Overall this course was excellent, and I found it extremely useful. I would highly recommend it. I ... more (38)"

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Format: Bespoke training
CPD: 30 hours for your records (depending on your requirements)
Certificate of completion

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.

Popular with...

This course has proven particularly popular among our customers in these roles:

Consultant
International Medical Manager
Principal Consultant
Quality Engineer
Regulatory Affairs Manager
Regulatory Affairs Specialist

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

Overall this course was excellent, and I found it extremely useful. I would highly recommend it. I wanted to understand the processes for developing compliant medical device software. I definitely got the necessary information to understand this better. Both excellent speakers and clearly extremely knowledgeable on the subject matter. Very impressive. I thought it would focus more on the development process (e.g. detail around how to implement EN 62304), but what this course demonstrated was that there is a lot more to consider. So that was a useful learning experience as well.

Nov 18 2024

Tom Clarke United Kingdom
Director, ISO Sense Consulting Ltd.

Jul 22 2024

Both speakers extremally knowledgeable and fantastic teachers. thoroughly enjoyed the course! Fantastic all around!

Neisha Kearney United Kingdom
Quality Associate, Axial

Nov 18 2024

[Speakers had] huge expertises. I accomplished what I wanted to achieve from this course.

Wicem Boumalouka France
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 Austria
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 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