Presented by
Management Forum
Practical Implementation of a Human Factors Study Training Course
This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products.
4-5 March 2025
+ 1-2 July 2025, 18-19 November 2025 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
- An Introduction to the Medical Device Regulation
- The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
- An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
- Managing Competence within the Medical Device Industry
- An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
- Practical Implementation of a Human Factors Study
- An introduction to Risk Management ISO 14971:2019
Course overview
This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products. We start at the planning stage, and cover all of the many challenges involved in preparing the study, running the interviews and dealing with the practical problems that can arise. We also include how to liaise with third parties such as the test venue staff, recruiters and of course the participants themselves.
The format of the training involves breakout sessions to practice the skills, and to share best practice.
Please note that this course is focused on human factors for medical devices and combination products only.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
Benefits of attending
- Learn practical skills to conduct your next human factors study
- Explore how to stay legal during the study
- Gain solutions to common problems that occur during a study
- Understand data collection methods
- Discuss moderating skills
Who should attend?
This training would be relevant for human factors specialists who undertake formative and summative studies for medical devices, and those who want to develop their expertise to a higher level.
This course will cover:
Background to Human Factors testing
- What are you trying to achieve in the test?
- What type of objectives should you set?
- What type of data are you trying to gather?
- Interviews or focus groups – which method is best?
Staying legal
- General Data Protection Regulation (GDPR) – how to design HF studies to comply with GDPR
- Institutional Review Board (IRB)/ethical approval – when you need it, and how to get it
- Sunshine act and Health Insurance Portability and Accountability Act (HIPAA) – rules for running the study in the US
Study preparation
- How to choose a test location
- How to schedule the participant interviews
- Monitoring progress – using a project planner
- Piloting – why you should run a pilot
- Incentives – setting a reasonable payment level
Study recruitment
- How to find a good recruiter
- How recruiters find participants
- How to help recruiters to get access to the right patient types
- How to work with the recruiter before, during and after the testing
- How to write a screener for a typical product test
- Common recruitment problems
Setting up the test interview
- Setting up the room - what to include
- How to lay out the test room
- Cameras – where to place them
- Where should the participant sit?
- Where should the moderator sit?
Structuring the test interview
- How to welcome participants and put them at ease
- Checking participant identities
- Introduction – what to include in the introduction
Moderating the test interviews
- The role of the test moderator in formatives and in summatives
- How to construct a moderator’s workbook
- How to work with the test observer / data analyst
- Children – how to include children and how to interview them
Moderating skills
- How to adopt the right mindset during the interview
- Listening skills
- Questioning skills
- Discussion skills for focus group moderators
- Empathy – how to achieve it and maintain it during the interview
Data collection
- Setting up the data set
- What types of data to include and exclude
- Full data set – what it is and how to create it during the testing
- Completing the paperwork – using the ALCOA method (attributable, legible, contemporaneous, original, and accurate)
- Quality control of the test outcomes – verifying and validating the data
- Adverse event reporting requirements
- How to deal with a faulty/broken device
- How to record protocol deviations
Common problems and how to deal with them
- Difficult / awkward / upset participants
- Noisy / interfering backroom staff
- Dealing with cancellations and last minute no-shows
- Dealing with late participants
- Participants who are very slow
- Injuries to participants (e.g. needlestick)
- Participants who fall ill during the test
- Participants with the wrong profile – what should you do?
Richard Featherstone
Knowledge Specialist Ltd
Richard has 20 years of experience in planning and performing human factors studies in the UK, United States, Australia and Europe. He is able to blend a deep understanding of the technical human factors requirements for FDA and MDR, with the many logistical challenges of running a successful study. He has run over 150 HF studies for medical devices, combination products and diagnostic devices over a 20 year period. He is an experienced trainer too, and can communicate the many complexities of HF studies clearly and effectively.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
4-5 March 2025
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 15314
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 28 Jan
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
1-2 July 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Timings may be different for each day
Course code 15315
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 27 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
18-19 November 2025
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 15316
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 14 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Run Practical Implementation of a Human Factors Study Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
