Summative evaluation and human factors validation
in-house implementation programme
- Expert-guided in-house implementation
- EU and US requirements
- Intermediate – advanced
- Last updated - June 2026
This programme is designed for medical device teams who want to conduct their summative evaluation in-house and reach a compliant, audit-ready result – with expert guidance at every stage.
A proven step-by-step process with ready-to-use templates, at a fraction of the cost of full consultancy.
- Build your URRA, Test Protocol, Moderator Guide and Final Test Report - with expert review and feedback specific to your device at every stage.
- Live expert sessions at key milestones to resolve questions and move forward with confidence.
- In-house competence your team retains after the programme ends.
- Course certificate upon successful completion of all stages.
+ templates
+ expert review
+ live sessions
From € 12,500
| Programme duration | up to 9 months |
Select your course plan
ONLINE
€ 399
Average completion time 8-22 hours
Total video duration 4.5 hours
CPD points 16
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Digital course companion
6 months access to the course and instructor
ONLINE LIFETIME
€ 499
Average completion time 8-22 hours
Total video duration 4.5 hours
CPD points 16
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Digital course companion
Lifetime access to the course and instructor
BLENDED
YOU ARE HERE
€ 999
Average completion time 15-29 hours
Total video duration 4.5 hours
CPD points 23
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Programme overview
This programme is designed to guide your team through the full summative evaluation and human factors validation process – from risk analysis and test planning, through to conducting the evaluation and producing an audit-ready final report.
Each stage is built around a real deliverable for your device, not theory or generic exercises. Your team does the work, supported by a structured step-by-step process, expert review of your actual documents, and a live session with your expert at every milestone before moving forward.
It covers three crucial stages in the summative evaluation and human factors validation:
Stage 1
URRA & Test Protocol
Define what to test and why. Risk analysis and test plan for your device.
Stage 2
Moderator Guide & dry run
Prepare and rehearse how your team will run the evaluation.
Stage 3
Summative Evaluation & report
Run the evaluation and produce an audit-ready final report.
Completion
Course certificate & evaluation
Course evaluation, and personal certificate issued upon full completion.
Every stage includes all of the following:
Expert-designed learning module
Structured content to prepare your team for the stage
Build your document with ready-to-use templates
Your team write the real deliverable for your device, using our ready-to-use templates.
Submit to experts
Submit your documents for expert review - specific to your device, not generic feedback.
Expert written feedback
Up to 2 rounds, 10-day turnaround per round
Live 60-min session
Resolve questions and align before moving forward
Refine and advance
Incorporate feedback and move to the next stage
Completion
Course certificate & evaluation
Course evaluation, and personal certificate issued upon full completion.
Benefits for you
Build the competence your team keeps
Your team builds the skills by doing the real work – on your actual device. That knowledge stays with your organisation long after the programme ends. Expert guidance at every milestone without consultancy cost
A regulatory expert reviews your work and meets with you at every stage. You get the oversight and assurance of consultancy – at a fraction of the price. Leave with documents ready for submission
You finish with a complete, audit-ready document set for your device. Real output your team produced, understands, and can defend.
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
Apply to become a validator for this programme
The instructors for the programme
The expert guidance in this programme comes from Custom Medical – an award-winning usability engineering team that conducts on average one summative evaluation per week for medical device manufacturers across Europe and the US.
Custom Medical designs user interfaces for medical devices and conducts formative and summative usability studies for all classes of medical devices, with a TÜV-certified QM system according to ISO 13485.
Dr. Michaela Kauer-Franz is the CEO of Custom Medical and a highly regarded trainer, consultant and entrepreneur in the medical device industry. She holds lectures on the design of medical and critical user interfaces at the Technische Universität Darmstadt and is part of the national standardization committees in Germany for Usability and User Experience.
She has extensive hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products. She has also received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award.
Dr. Jonas Walter is Head of Operations, Senior Consultant and Lead Trainer at Custom Medical. With a background in psychology and neuroscience, he is the company’s lead expert for regulatory usability engineering worldwide, helping medical device and IVD manufacturers translate complex international requirements into efficient, compliant usability strategies.
He advises global manufacturers across all device classes on regulatory strategy, usability engineering, validation planning and lean documentation under MDR/IVD-R, FDA, IEC 62366-1 and NMPA requirements. His experience spans from low to high risk profile devices, including cardiac implants, neuroendoscopic class III devices, diabetes care, dental products, AI-enabled diagnostics and IVD applications. As a trainer, he has enabled more than 100 international professionals in regulatory usability engineering and human factors.
Programme modules
Learn about the right terms in the context of usability and human factors engineering. This section will provide you with the most relevant terms and definitions that you need to know to be able to stand your ground in the field.
The conduct of a summative evaluation takes a lot of time and effort. In this you will learn to tailor your efforts to the expectations of the regulatory authorities. Learn when a summative evaluation is necessary – and when it is not.
In the next step you analyse the tasks of your users and understand the associated risks. Based on this so-called use-related risk analysis, you are enabled to choose the right tasks to test for your summative study.
A sound test protocol is half of what you need for regulatory authorities. In this part of the training, you learn the do’s and don’ts of a summative test protocol and receive feedback to your personal one.
Conduct your first summative evaluation with the feedback of experts. Record your dry run and receive detailed feedback on moderation, setup and root cause analysis from experts with years of experience.
Your study is done, you have the data. In the last part of the training, we will guide you through the process of data analysis and writing your summative test report. The training ends with a feedback on your report to give you the confidence to move ahead.
NOTE – The course modules are subject to change.
Frequently asked questions
The blended course consists of two parts: the online course and two half-day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions.
Yes, you can.
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 8-22 hours to finish on average.
You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like.
The two half-day live virtual classroom sessions, take approximately 7 hours in total.
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
If you wish to buy 3 or more seats, we invite you to reach out using the contact form to discuss discount options. Please note, if there are more than 5 people from your organisation wising to take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
If you complete the final exam within 6 months of enrolment, you will have lifetime access to the online course (conditions apply). If you do not, your course access will expire after 6 months.
The maximum number of participants for the live virtual classroom session is 8.
There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom sessions. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.
If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the first classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom sessions.
There are no pre-requisites for this course.
Dr. Michaela Kauer-Franz is TÜV Rheinland certified medical devices usability expert. She works in the German standardization committee for Ergonomics, Usability, and User Experience and has extensive knowledge as an usability engineer. In 2013 she founded the usability engineering company Custom Interactions and is heading the medical branch Custom Medical since 2017. Besides this, she is a lecturer for the design of medical and critical user interfaces at the Technische Universität Darmstadt.
We offer a number of payment methods including credit card,
GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you
are buying from. If you cannot find your country on the list at checkout or you
are not given wire transfer as a payment method, you can submit your order via
our invoice order
form.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completion of this blended course, you are awarded 16 CPD points.
Your course certificate will display the exact number of CPD points. Read more.
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IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?