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Medical Device Usability and IEC 62366


8 - 9 June 2022


Delivered online using Zoom and UsePaq (a usability software service)


£850 per delegate (+ VAT)

Discounts available until 11 May 2022

10%: £765 (+ VAT)

15%: £722.50 (+ VAT) for colleagues of past attendees from the same company or for 3 or more delegates from the same booking (can be from different companies)


Book a place


Contact: Suzy Robertson

Tel: +44 (0)771 954 4455


MDU Programme Programme

Course Overview

'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(R2018)
  • Select and apply usability techniques
  • Develop testable requirements for usability
  • Manage the risk of use error
  • Develop a usability engineering process
  • Document usability activities in the usability engineering file and HFE report (US)

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.

“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
Klaus Mayntzhusen, Medical Engineer, DELTA

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

About the Presenter

Nick Bradley

Dr Nick Bradley is the manager and founder of BERGO, a leading usability consultancy with extensive training experience in the medical device industry.

Nick assists, and delivers training for, a range of medical device manufacturers across Europe, North America and Southeast Asia in all aspects of the usability engineering process.

He holds a PhD in Human-Computer Interaction (HCI) from Strathclyde University, a BSc in Ergonomics from Loughborough University and a Diploma in Professional Studies (DPS) from the same institution.

Nick has published work in a variety of application areas in healthcare and HCI. He is a Graduate Member of the Institute of Ergonomics and Human Factors (IEHF), a full member of the Human Factors & Ergonomics Society (HFES) and a reviewer for the Journal of Applied Ergonomics.

Past Courses

Over the last 10 years, we have trained and certified over 960 delegates from over 250 medical device organisations across Europe and South East Asia, including manufacturers, software companies, regulatory and notified bodies, and product design agencies.

The following companies 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, 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, Boehringer Ingelheim, BONESUPPORT AB, Boston Scientific, Breas Medical, Cambridge Cancer Genomics, Canon Medical Research Europe Ltd, 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, E.M.S. Electro Medical Systems, Eakin, Elekta Ltd, Elos Medtech, 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, Irish Medicines Board, ITL Asia Pacific Sdn Bhd, JEB Technologies, Johnson & Johnson, KCI Medical, Kinneir Dufort, Kivex Biotec Ltd, Klean, Korea Testing Laboratory, Laerdal Medical AS, Leo Cancer Care Ltd, LEO Pharma, LifeScan, 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, 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, Pfizer, Philips Electronics Nederland, Philips Respironics, Precision Robotics, Presafe Denmark A/S, Prevas AB, Promedon, Qiagen, QuantuMDx, Quotient Limited, Radiometer, RB, Riemann A/S, Robert ApS, Roche Diagnostics, RUCK TMED, S3 Group, SHL Group AB, Siemens Healthcare GmbH, Siemens Healthineers, Silicon & Software Systems Polska, SLE Ltd, Smart Process Solutions Ltd, Smiths Medical, SPD Development Company Ltd, Strathclyde University, Straub Medical, Surgical Materials Testing Laboratory (SMTL), SurgiCube International, Svensk konstruktionstjänst AB, Swansea University, Symbioteq, Synecco, TATA ELXSI LTD, Tcoag Ireland Ltd, Technolution A/S, Teleflex Medical, Terma A/S, Teva Pharmaceuticals, Thermo Fisher Scientific, Toshiba Medical Visualization Systems Europe Ltd, Trate AG, Tryg Forsikring, UCB, Unisense FertiliTech A/S, University of Liverpool, Unomedical A/S, Varian Medical Systems UK, ViCentra, Visiopharm, Vitalograph, Vitreq BV, Wandercraft, Welch Allyn, Widex A/S, Xellia Pharmaceuticals, Zimmer Biomet