Summative Evaluation / Human Factors Validation

A summative evaluation / human factors validation demonstrates that your medical device or IVD can be used safely by its intended users without any unacceptable risks associated with its use. It is therefore a key component of the approval process for your product.

We support you throughout the entire process – from study planning and recruiting suitable participants to conducting, analyzing, and documenting the study. Depending on regulatory requirements, you will receive the results, for example, in the form of a written report that includes a root cause analysis.

How we help

We provide methodologically sound support for your summative evaluation, from study design through to the final written report – with a clear focus on regulatory requirements, realistic test conditions, and robust results, e.g., for CE and FDA.

Advice on the appropriate study design
Recruitment of participants
User training in accordance with the IFU or training materials (if necessary)
Providing the Laboratories – including equipment
Professional execution in the lab and in the field
Streaming / On-site support
Evaluation, including root cause analysis
Written report and submission of all relevant documents

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How does a summative evaluation work at our company?

An expert is discussing plans for a summative evaluation/human factors validation of a medical device with clients.

01. Study Methodology & the Right Regulatory Basis

We determine what requirements your summative evaluation or human factors validation must meet and how to methodically structure the evidence of safe use. In doing so, we take into account your product, your user groups, your hazard-related use scenarios, and your risk analysis, among other factors.

An expert is setting up a realistic test scenario in the Medical Usability Lab for a summative evaluation.

02. Preparation for study – We Create the Right Conditions

We will design the study, recruit suitable participants, and prepare the test environment, product, and materials. If necessary, we will also provide user training in accordance with the Instructions for Use or training materials, including the appropriate decay time.

Conducting a summative evaluation in the Medical Usability Lab, observing the application under realistic conditions

03. Conducted under realistic conditions

We conduct the summative evaluation / human factors validation under controlled and realistic conditions. You are welcome to watch live – either on-site or via livestream. At the same time, we document the study’s execution, for example, on video.

An expert reviews the results of a summative evaluation on screen and prepares the regulatory classification.

04. Analysis of the results & regulatory classification

We analyze the results, assess any use errors that have occurred, and coordinate with your risk management team. This ensures that the results are not merely described, but are clearly contextualized in terms of usage, risk, and safe application.

Documents for a Summative Evaluation with a Written Report/Human Factors Validation Report

05. Documentation – You will receive documentation, e.g., for CE and FDA

Depending on your needs, you will receive, for example, a structured written report containing all relevant results and analyses. We are also happy to assist you with any additional regulatory questions and documentation.

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Certified for excellence

We are certified to ISO 13485 and ISO 27001. This allows us to combine verified quality processes with secure handling of sensitive data – specifically for projects in the medical device and IVD sectors.

ISO 13485
ISO 27001

You can find our certificates here.

We are certified to ISO 13485 and ISO 27001

Our references in summative evaluations / human factors validations

Der AMX Morcellator activeCut — AMX Morcellator activeCut – An Innovative Medical Device on its way to MDR Approval

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Healthyfy – the innovative telemedicine software

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fasciotens – Solutions for complex abdominal wall pathologies

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Our References

Why Custom Medical?

Reach your goals efficiently with our process: From study design to the written report – our step-by-step process guides you through summative evaluation and human factors validation, providing robust evidence for your regulatory documentation.

Fully equipped: Our medical usability labs and equipment enable realistic testing scenarios – from a doctor’s office and hospital room to a fully equipped operating room.

Recruiting the right participants: Our user databases cover a wide range – from laypeople to experts. We are accustomed to recruiting internationally, ensuring that the ideal participants for your formative evaluation are available.

We have an NPS of 86 (as of 2025): Customer satisfaction is extremely important to us. That is why we calculate the Net Promoter Score after every project. All projects in 2025 combined result in an NPS of 86 – which the score’s developers describe as “world-class.”

Meeting the regulatory requirements of various markets: Medical devices and IVDs are often approved internationally. We are thoroughly familiar with the requirements of your target markets. Our locations in the EU and the U.S. also facilitate the conduct of international clinical trials in the world’s two largest medical technology markets.

On average, we conduct one summative evaluation or human factors validation per week: We have extensive experience with international studies, and you can benefit directly from that. Whether it’s finding the right participants or the right laboratories – we can provide many of these resources directly and also have an excellent network.

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Our Laboratories & Equipment

Our Medical Usability Lab provides the ideal environment for summative evaluations and human factors validation testing of medical devices and IVDs. Here, relevant usage scenarios can be simulated in a realistic manner – under controlled conditions and with professional technical equipment.

From the observation area, you can follow the study in real time without affecting the test situation. Appropriate camera and audio equipment allows you to reliably observe and record user errors, critical situations, and user behavior.

This creates a solid foundation for the evaluation, root cause analysis, and written report.

Laboratories and Equipment

Conducting a formative evaluation in the Medical Usability Lab

Knowledge of summative evaluations / human factors validations

Learn what matters most in a summative evaluation or human factors validation—from proper study design and realistic test conditions to robust documentation for CE and FDA approval.

Webinars

Do You Really Need a Summative Evaluation or Human Factors Validation? (On-Demand)

What is it about?

Sooner or later, a central question arises in many MedTech projects:

Do we need a Summative Evaluation or Human Factors Validation Study for our device?

Especially with existing products, changes to the user interface or existing usability data, the answer is often less clear than it first appears.

In this webinar, Dr. Michaela Kauer-Franz (CEO Custom Medical) and Dr. Jonas Walter (Head of Operations Custom Medical) explain how typical project situations can be evaluated – and when a Summative Evaluation / Human Factors Validation Study is probably necessary or not.

In this webinar, you’ll learn:

What role MDR/IVDR, IEC 62366-1 and the FDA Human Factors Guidance play in the decision on Summative Evaluations / Human Factors Validations
How you can assess whether there are hazard-related use scenarios for your product that require usability validation.
When existing usability or human factors data can be used by other products.
How changes to the user interface influence whether a new study is required – or not.
In which cases only certain parts of the user interface need to be tested.
In which situations a rationale may be sufficient.

What is the language?

English

Who is hosting this webinar?

Dr. Jonas Walter, Head of Operations and Dr. Michaela Kauer-Franz, CEO

When does it take place?

This is a pre-recorded webinar. After registering, you will receive a link that you can use to view the webinar at any time.

How can I register?

You can find the registration here.

Your Perfect Timeline for Summative Evaluations & Human Factors Validation Testings (On-Demand)

What is it about?

How much time does a summative evaluation/human factors validation really require, and how should you plan the individual steps to ensure everything runs smoothly?

In this webinar, Dr. Michaela Kauer-Franz, the CEO of Custom Medical, will demonstrate how to structure and streamline your validation study — from initial planning to final submission. You will receive a proven timeline with realistic timeframes and learn how to meet all requirements, even under tight project conditions.

In this webinar, you’ll learn:

How to plan your timeline — from the first document check to submission
Which steps require how much time, including test preparation, recruiting, implementation, analysis, and documentation?
How to avoid typical bottlenecks in practice and how to parallelize
Which tools and strategies have proven their worth in over 400 projects?

What is the language?

English

Who is hosting this webinar?

Dr. Michaela Kauer-Franz, CEO

When does it take place?

This is a pre-recorded webinar. After registering, you will receive a link that you can use to view the webinar at any time.

How can I register?

You can find the registration here.