Our usability and human factors services.

We bring together regulatory knowledge, academic research and practical experience to assist you with small to large projects.

Formative evaluations

Formative evaluations are carried out throughout product design and development to inform your design decisions. Various methods and techniques can be used. Some involve collecting data from users, while others involve usability experts inspecting the design of the user interface.

We will listen to you to get an accurate and complete understanding of your objectives and design questions that need answered. We will then recommend a suitable technique, such as usability testing, heuristic evaluation or cognitive walkthrough.

For usability testing, we can either run the full study ourselves or work in collaboration with your team. We prepare protocols, recruit participants, organise venues, collect data through observation and interviews, and develop reports.

We always apply techniques in accordance with IEC 62366-1:2015+AMD1:2020 and guidance from the FDA and MHRA. Since 2009 we have conducted over 40 evaluations (both formative and summative) across Europe and North America involving various types of devices.


Summative evaluations

A summative evaluation (or human factors validation test) is carried out at the end of development when the user interface has been finalised. Evidence is collected to show that the device can be used safely and effectively by intended users in the use environment.

All hazard-related use scenarios (or critical tasks) are evaluated, including information for safety.  An adequate level of realism needs to be created to confidently make generalisations on device-use safety for conditions of actual use.

We are experts in designing and running summative studies. We can either run the full study ourselves or work in collaboration with your team. We prepare protocols, recruit participants, organise venues, collect data through observation and interviews, and develop reports.

Our summative evaluations are always carried out in accordance with IEC 62366-1:2015+AMD1:2020 and guidance from the FDA and MHRA. Since 2009 we have conducted over 20 summative evaluations across Europe and North America involving various types of devices.


Usability analysis starts early in product design and development and is updated iteratively when new insights on product use are uncovered, for instance in a formative evaluation.

Usability analysis consists of analysing how tasks are performed by users (task analysis) and the ‘use errors’ they may commit (use-related risk analysis) to make the device efficient, safe and natural to use.

Supported by our specialist software Usepaq, we assist clients with applying a wide range of analysis techniques and use guidance in ANSI/AAMI HE75:2009 (2018) to ensure best practice principles are followed.

For more detailed user interface design, we also have experience with techniques such as participatory design prototyping, anthropometric analysis, and workload assessment (NASA TLX).


Usability documentation

To satisfy IEC 62366-1:2015+AMD1:2020, manufacturers must prepare a Usability Engineering file consisting of several deliverables. For FDA premarket submissions in the United States, manufacturers should also prepare a summary HFE report.

To apply usability and human factors engineering effectively to your medical devices, a Standard Operating Procedure (SOP) should be developed in your organisation to ensure best practice is followed and regulatory requirements are met.

Using in-house templates that have evolved from serving clients globally in the medical device industry over 13 years, we assist clients with preparing all forms of usability documentation for both new devices in development and marketed devices with a User Interface of Unknown Provenance (UOUP).

Our specialist software Usepaq can be used to generate deliverables for the UE file, saving considerable time and effort.  We can also perform a gap analysis to determine any missing elements of your existing documentation.


User research

User research is carried out at the earliest stages of product design and development to get users’ feedback on early design concepts and marketed devices. This helps prioritise their needs, providing focus for design.

A mixed method approach is often taken to collect quantitative and qualitative data from observing marketed devices being used in practice, speaking to users in interviews and focus groups, collecting users’ opinions in surveys, and reviewing past incidents in desktop reviews.

We assist with all types of research projects.  We listen to you to get a complete understanding of your objectives and research questions. We can assist with both planning and executing the project, and can work independently or collaboratively with your project team.

We are skilled in preparing research protocols, recruiting participants, managing ethical review applications, organising venues, collecting data, and developing reports with recommendations.


Human factors training

In recent years, there has have a growing demand for training on applying usability and human factors engineering to medical devices.  This has been fuelled by:

  • a growing body of literature on the topic which manufacturers need to understand and implement, covering standards, guidance documents, academic articles, and textbooks.
  • a requirement in IEC 62366-1:2015+AMD1:2020 that manufacturers must have personnel competent on carrying out usability engineering activities based on appropriate education, training, skills and experience.

Since 2009, we have trained and certified over 1100 people from over 260 organisations globally on the topic.  We deliver both open-enrolment courses, and onsite courses tailored to your organisation.

Delegates who join our courses get a comprehensive understanding on how to effectively implement the usability engineering process and how to efficiently document activities for regulatory bodies.  Our intensive, interactive courses also equip delegates with valuable practical skills for conducting their own project work.


Upcoming training courses

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.

What our clients say about us

Bergo has assisted our company with several usability studies over the last few years. They designed and executed those studies to the highest standards, helping us to use their findings to make important design decisions whilst ensuring regulatory requirements in usability and human factors were met.

Dr Francesco Robotti

Co-Founder & Chief Operating Officer, Hylomorph AG

In my 15 year career I have worked on multiple medical devices submissions and amendments. Dr Nick Bradley and Bergo have been by far the most effective organisation I have worked with. Nick’s depth of knowledge as a UE specialist, skill as a study designer and moderator, pragmatism and effective communication drove our progress, ultimately resulted in a successful CE and UKCA certification.

Gregor Timlin

Vice President, Product Design, Closed Loop Medicine

UNEEG Medical commissioned Bergo to carry out a user research study to assist the business in making strategic decisions on the development of a system for patients with Type 1 diabetes. Dr Nick Bradley at BERGO conducted the study and presented the findings to our management team. We were very happy with Bergo’s quality of work and professionalism, helping us answer all the questions set by our team. We would highly recommend Bergo’s user research service.

Marie-Louise Little

Director of Strategy & Business Development, UNEEG Medical (part of the T&W Medical Group)