On-Demand Webinar:
Do You Really Need a Summative Evaluation or Human Factors Validation?
Webinar speaker: Dr. Jonas Walter & Dr. Michaela Kauer-Franz, both experts on international usability engineering.
Does this sound familiar?
Usability engineering is now standard in the development of medical products.
But when it comes to the question of whether a summative evaluation or human factors validation study is necessary, uncertainty arises in many projects.
Is a Summative Evaluation / Human Factors Validation really necessary?
Or is a sound rationale enough?
Can existing data (e.g. for other products or PMS) be used instead of a study?
And how do the FDA or notified bodies decide in such cases?
The question“Do You Really Need a Summative Evaluation or Human Factors Validation?” is therefore not always easy to answer, especially for products that are already on the market – or are based on a predecessor.
This is exactly where our webinar comes in.
We show you in which cases a Summative Evaluation / Human Factors Validation is actually necessary – and when a well-founded rationale can be sufficient.
Topics covered in the webinar
In this webinar we will show you:
- 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.
The Details:
When is the webinar, "Do You Really Need a Summative Evaluation or Human Factors Validation?," taking place?
This is a pre-recorded webinar. After registering, you will receive a link allowing you to view the webinar at any time within 90 days.
Can I ask questions?
Yes, you can ask questions at any time during the webinar. You will receive an answer via email afterwards.
How long will the webinar last?
The webinar will last approximately 23 minutes
Who should attend the webinar?
This webinar is aimed at experts from the fields of regulatory affairs, quality management, product management, usability engineering and development who are involved in the development or further development of medical devices or IVDs.
The webinar is particularly relevant for teams who need to decide whether a Summative Evaluation / Human Factors Validation is required for their product or whether existing data and documentation may be sufficient.
Typical participants work on projects in which, for example:
- a new product is to be launched on a market,
- changes are to be made to the user interface of an existing product,
- existing usability or human factors data from other products should be used if possible, and
- to generally clarify whether a study is necessary or not.
What is the language of the webinar?
The webinar will be held in English.
Who are the speakers - Dr. Jonas Walter & Dr. Michaela Kauer-Franz?
Dr. Jonas Walter is a regulatory usability expert with over 10 years of experience. Key points:
- Head of Operations at Custom Medical
- Expert for International Usability Engineering strategy and application
- Hands-on experience with IVDs, medical devices and combination products from low to high-risk in more than 80 international projects
- Trainer of usability engineering at Medical Device HQ.
Dr. Michaela Kauer-Franz is a usability expert with over 20 years of experience. Key points:
- CEO of Custom Medical, with locations in Germany and the US.
- Over 400 successfully completed medtech projects. This includes approximately one user study per week.
- TÜV-certified usability expert for medical devices
- Trainer of usability engineering at Medical Device HQ.
- Author and speaker.
Register for “Do You Really Need a Summative Evaluation or Human Factors Validation?” now for free
In this webinar you will learn how to assess whether a Summative Evaluation / Human Factors Validation is required for your product.
We show typical decision-making situations from practice in a structured way and explain when a study is necessary and when existing data or a sound rationale may be sufficient.