The Creating a Human Factors and Usability Engineering File workshop aims to equip delegates with the ability to make decisions on which filing route they should take when putting together a Usability Engineering File for a product. The training gives delegates an in-depth understanding of all the elements of the Usability Engineering File and Usability Engineering process in-line with the expectations from IEC62366-1 and the FDA.

This workshop is recommended for anyone involved with the research, design and development of a Medical Device or Combination Product. The workshop will cover all aspects of the file including Use Specifications, User Interface Evaluation Plans, Use Risk Analysis (Overview), User Interface Specifications, Formative Evaluations (Overview), Summative Evaluations (Overview) and HFE Summary Report.

Workshop programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

9:10 Overview of the Regulatory Landscape

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• Learn what is required for Human Factors Engineering in Medical Devices and Combination Products
• Discuss the latest changes to regulations

10:00 Expectations from the IEC62366-1

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• Discuss each element of the Human Factors and Usability Engineering Process
• Provide an overview of the Legacy Devices (Annex C) clause in IEC62366-1 and what evidence Manufacturers need to supply regulators with to qualify for this route to market

10:15 Creating a Use Specification

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• Information to include in a Use Specification and how it inputs into all UE documentation and activities

10:30 Morning Coffee

11:00 Creating a User Interface Evaluation Plan

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• What to consider when creating a User Interface Evaluation Plan,
• How this this will affect the overall project delivery plan.
• Considerations for packaging, Instructions and Training

11:20 Considerations when creating a use related risk analysis

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

•Task Analysis

11:40 Conducting Formative and Summative Evaluations

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• What to consider when producing these evaluations
• Looking at IFU testing

12:00 Generating a HFE summary report

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio

• Learn what you need to consider
• How to remain FDA compliant

12:30 Chairman’s Closing Remarks and Close of Day One

Paula Wood

Paula Wood, Director, Human Factors Centre Ltd
View Bio



Paula Wood

Paula Wood

Director, Human Factors Centre Ltd

Paula Wood

Director, Human Factors Centre Ltd
Paula Wood

Paula is the Founder and Director of the Human Factors Centre Ltd. She has a background in Human Factors, Usability, User Research, User Experience and Product Design. Paula has worked with various Healthcare start-ups, Medical Device Manufacturers and Pharmaceutical companies to provide training, support and mentorship when constructing Human Factors and Usability Engineering Files. She is a certified Practitioner and has moderated numerous Formative and Summative Evaluations across Europe, USA and China.

Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
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