Medical Device Usability and IEC 62366 (10-11 September 2025)
An intensive, interactive 2-day course on how to effectively implement a usability engineering process.
Course Description
Usability (or human factors) engineering has become a hot topic in the medical device industry. Manufacturers are under increasing pressure to demonstrate compliance to IEC 62366-1:2015+AMD1:2020 Application of Usability Engineering to Medical Devices.
Further, manufacturers may need to prepare a Human Factors Engineering report for the FDA and consider ANSI/AAMI HE75: 2009 (R2018) Human Factors Engineering – Design of Medical Devices.
What you will learn
Delegates will learn how to:
- Achieve compliance with IEC 62366-1:2015+AMD1:2020
- Use design guidance in ANSI/AAMI HE75:2009/(R)2018
- Conduct user research, task analysis and use-related risk analysis (URRA)
- Generate user interface requirements
- Conduct formative and summative evaluations
- Efficiently implement a usability engineering process
- Prepare deliverables for the UE file, including the HFE report for the FDA
The course consists of a mixture of lectures, case studies and workshops which can be based on examples brought to the course by the participants.
Who should attend
The course is targeted at (but not limited to):
- Product design engineers
- Project managers
- Regulatory managers
- R&D personnel
- Risk management staff
- Quality assurance managers
- Clinical trial managers
Book your place
Details
*10% discount for early registrations. 15% discount for colleagues of past attendees and for 3 or more delegates from the same booking. All discounts expire after 13th August 2025.
About the Presenter
Nick founded BERGO in 2009 after accumulating a wealth of experience in usability and human factors across healthcare, medical technology, oil & gas, nuclear, and defence industries.
Nick now specialises in medical devices and assists clients globally with all aspects of applying usability and human factors engineering to medical devices. He also delivers all BERGO’s training courses, which over 1200 people have attended.
He holds a PhD in Human-Computer Interaction (HCI) from Strathclyde University and a BSc (Hons) in Ergonomics from Loughborough University. He is also a published author of various research papers, articles and book chapters.
Nick is a member of the Chartered Institute of Ergonomics and Human Factors (CIEHF), a full member of the Human Factors and Ergonomics Society (HFES) and a reviewer for the Journal of Applied Ergonomics.
The training was comprehensive and enlightening. It provided a deep understanding of usability challenges, equipped with templates and techniques for conducting evaluations and for compiling a usability engineering file in line with applicable standards. The workshops added practical relevance, making the learning experience invaluable.
Mélanie Combes
RAQA and Usability Lead, Wandercraft
When completing my training, Nick was highly professional, and informative as he was able to answer all questions thrown at him and you can tell he cares about usability in medical devices. I highly recommend all companies who sell medical devices take part in this course as the contents of this course were detailed.
Lois Taylor
Clinical Research Assistant, Bedfont Scientific Ltd.
Early on in my career move into Human Factors, I attended the BERGO Medical Device Usability Training which I found hugely beneficial in improving my understanding of HFE principles, techniques, compliance requirements and deliverables. The course went into theoretical detail while also working through practical examples which helps you put the course content into practice. Highly recommend attending this course if you want to be equipped with the right tools to deliver an optimal and safe device design.
Kate Molan
Human Factors Design Engineer, Structural Heart, Medtronic
This course has a very good balance between the theoretical and practical aspects of Usability Engineering. We brought home motivation, a deeper understanding, and several techniques that can be seamlessly implemented into our design and development projects. Highly recommended for organisations that take product safety and ease of use seriously.
Irvin Mangwiza
Project Manager, DELTA
I had the privilege of participating in this course. We explored various methodologies and techniques to ensure that medical devices are not only effective in delivering care but also intuitive and safe for healthcare professionals and patients alike. The trainer Nick shared his wealth of expertise and provided valuable insights. His guidance and practical examples greatly enriched the learning experience and equipped me with real world examples of how to best apply the learnings from the course.
Nathan Brennan
Product Designer, Axial3D
Past Courses
The following organisations, which include manufacturers, regulatory and notified bodies, and academic institutions, have attended our past courses:
3Shape, Aarhus University, Actavis, Actura A/S, AD Modum R&D, Adept Water Technologies A/S, Aerogen Ltd, Agfa NV, Agilent Technologies Denmark ApS, Akademi Arnwulf AB, ALK Abelló, Alkermes, Altran Sweden AB, Ambu A/S, Amgen, Amo Uppsala AB, Aniba Consulting, ANT Neuro, Arjo, Association of Malaysian Medical Industries (AMMI), AstraZeneca, Aurena Laboratories AB, B. Braun Medical, Bach Polymer Consulting, Bang & Olufsen Medicom A/S, Baxter Healthcare Ltd, Becton Dickinson, Bedfont Scientific Ltd, Bespak Europe Limited, Bio-Medical Research Ltd, BioPorto Diagnostics A/S, Biosensors Interventional Technologies Pte Ltd, Biotage AB, BK Medical, Bluesail New Valve Technology Pte.Ltd, BluSense Diagnostics ApS, BlueBridge Technologies, bMotion Technologies, Boehringer Ingelheim, BONESUPPORT AB, Boston Scientific, Breas Medical, Cambridge Cancer Genomics, Canon Medical Research Europe Ltd, Capgemini, Carmel Pharma, Closed Loop Medicine, Cochlear Bone Anchored Solutions AB, Coloplast A/S, Combitech AB, Contura International A/S, ConvaTec, Concateno PLC, Cook Ireland Ltd, Cook Medical, Creganna Medical, Croma-Pharma, Crospon Ltd, Dako, Danish Health Authority (Sundhedsstyrelsen), Dawn Health, DELTA, Demcon, Designing Science, DiaSorin S.p.A., DORC International BV, Dräger, DTR Medical, Dyson Technology Ltd, Eakin Healthcare, Elekta Ltd, ELITechGroup S.p.A., Elos Medtech, E.M.S. Electro Medical Systems, Endo Pharmaceuticals, Epsilon Embedded Systems AB, ESCP Europe, Ferring Pharmaceuticals A/S, Ferrosan Medical Devices, Flexicare, Flusens ApS, Fotona, Galderma, GC Aesthetics, Gerresheimer Bünde GmbH, Getinge Group, GlaxoSmithKline, GMMI Sdn Bhd, Goode Solutions, Grifols, Hamiton Medical, Health Enterprise East Ltd, Health Products Regulatory Authority, HeartSine Technologies Limited, HemoCue AB, HypoSafe A/S, Icotec, Imnovus Ltd, Imperial College London, InnoCon Medical, Integra Lifesciences, Intertek, Invacare, IQ Endoscopes, Irish Medicines Board, ITL Asia Pacific Sdn Bhd, Javelo Health, JEB Technologies, Johnson & Johnson, Kardium Inc., KCI Medical, Kinneir Dufort, Kivex Biotec Ltd, Klean, Korea Testing Laboratory, Laerdal Medical AS, Leo Cancer Care Ltd, LEO Pharma, LifeScan, LumiraDx, Luto Ltd, Maddison Limited, Magstim, Malaysian Medical Device Authority, Maquet Critical Care AB, Valdecilla Biomedical Institute, Mectalent Medical Services, MED-EL, Medical Device Research Center, Samsung Medical Center, Medicim, Medicologic A/S, Medicom Innovation Partner, Medtechtomarket Consulting Ltd, MedTrade Products Ltd, Medtronic, MEQU ApS, Merck, Mind Media B.V., Mölnlycke Health Care, Mylan, National Standards Authority of Ireland, neoSurgical, Neurodan A/S, NextStaffing UK Limited, NNE Pharmaplan, Norgine, Novartis Pharma AG, Novo Nordisk A/S, NRT - Nordisk Røntgen Teknik A/S, Occlutech, Odstock Medical, Oftavinci Research BV, Olympus KeyMed, Olympus Surgical Technologies Europe, Gyrus Medical Ltd, Olympus Winter & Ibe GmbH, OMRON Healthcare, OpenHydro, Origio, Orion Diagnostica Oy, Össur, Oticon A/S, Owlstone Medical, Oxford Instruments, PA Consulting, PDD Group Ltd, Pelican Healthcare, Pennine Healthcare, Pfizer, Philips Electronics Nederland, Philips Respironics, Precision Robotics, Presafe Denmark A/S, Prevas AB, Promedon, Qiagen, QuantuMDx, Quotient Limited, Radiometer, Reckitt Benckiser, Riemann A/S, Robert ApS, Roche Diagnostics, RUCK TMED, S3 Group, Sagentia, SHL Group AB, Siemens Healthcare GmbH, Siemens Healthineers, Silicon & Software Systems Polska, SLE Ltd, Smart Process Solutions Ltd, Smiths Medical, SPD Development Company Ltd, Spotless Interactive, Strathclyde University, Straub Medical, Surgical Materials Testing Laboratory (SMTL), SurgiCube International, Svensk konstruktionstjänst AB, Swansea University, SWORD Health, Symbioteq, Synecco, TATA ELXSI LTD, Tcoag Ireland Ltd, Technolution A/S, Teleflex Medical, Terma A/S, Terumo Aortic, Teva Pharmaceuticals, Thermo Fisher Scientific, Toshiba Medical Visualization Systems Europe Ltd, Trate AG, Tryg Forsikring, UCB, Ulster University, Unisense FertiliTech A/S, University of Liverpool, Unomedical A/S, Varian Medical Systems UK, ViCentra, Vision RT, Visiopharm, Vitalograph, Vitreq BV, Wandercraft, Welch Allyn, WhiteSwell Ltd, Widex A/S, Xellia Pharmaceuticals, Xiros Ltd, Zimmer Biomet.