On-Demand Webinar:
Human Factors and Usability Engineering for Combination Products
Webinar speaker: Dr. Michaela Kauer-Franz, expert on international usability engineering.
Does this sound familiar?
Human factors and usability engineering are now standard in the development of medical products. However, as soon as it comes to combination products, uncertainty arises in many projects.
Which requirements apply at all? Which ones apply in the context of FDA or ANDA?
What distinguishes combination products from “classic” medical devices?
What role does a threshold analysis play?
When are additional human factors studies required?
And which regulatory path is relevant for my product?
For combination products in particular, the effort required depends heavily on a few key decisions – such as the target market, the chosen approval route or possible differences to a reference product.
And this is exactly where our webinar comes in.
We will show you which human factors requirements apply to combination products in the EU and US markets, how regulatory paths differ – and how you can systematically derive the right approach for your product.
Topics covered in the webinar
In this webinar we will show you:
- What exactly a combination product is – and which product types are included.
- Which regulatory requirements apply to human factors in the EU and US markets.
- Which FDA guidelines are relevant for combination products and how they interact.
- The differences between human factors for medical devices and combination products.
- How the ANDA approval process works and when it is relevant for your product.
- What role threshold analysis plays and how it determines other human factors activities.
- When additional human factors studies are required – and when they are not.
The Details:
When is the webinar, "Human Factors and Usability Engineering for Combination Products," 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 49 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 approval of combination products.
The webinar is particularly relevant for teams that need to clarify which human factors requirements apply to their product and what the appropriate regulatory pathway is – especially in the EU or US market.
Typical participants work on projects in which, for example:
- a combination product is developed or prepared for a new market
- the first target market (EU vs. US) and the regulatory route (e.g. ANDA) must be determined,
- it must be decided whether and which human factors studies are required
- there is general uncertainty about how to implement human factors requirements for your own product
What is the language of the webinar?
The webinar will be held in English.
Who is the speaker - Dr. Michaela Kauer-Franz?
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 “Human Factors and Usability Engineering for Combination Products” now for free
In this webinar you will learn which human factors requirements are relevant for your combination product – depending on the target market, regulatory path and possible differences to a reference product.
We show typical decision-making situations from practice and explain how you can systematically derive the right human factors approach for your product.