Discover our webinars
Stay up-to-date and expand your knowledge with our latest webinars! We regularly offer online sessions on important topics related to medical devices, IVDs and healthcare products. From the latest developments in user interface design to regulatory requirements and post-market surveillance, we provide you with valuable insights and practical knowledge.
Discover the next dates and topics below. Reserve your spot now and benefit from the expertise of our specialists. We are looking forward to your participation!
These are the next dates
Live February 02 4:30p.m. CET – Wellness or Medical Device? Here’s what the new FDA guidance says.
What is it about?
Many products start out as general wellness products – but during development, the line often becomes less clear. As features, claims, and UX evolve, teams start to wonder:
Is this still wellness – or already a medical device? How would the FDA interpret this today?
Other products where classified as medical devices at the beginning of the development. Here one question is:
Is this still true with the updated guidelines?
That is exactly what this webinar is all about. In this webinar, Dr. Jonas Walter and Dr. Michaela Kauer-Franz break down what the FDA’s updated General Wellness guidance means in practice – and how to assess borderline products early and realistically.
In this webinar, you’ll learn:
- What the FDA’s updated interpretation means for general wellness products, including apps, wearables, and digital health solutions
- How the FDA distinguishes between general wellness intent and medical device intended use – and why this distinction is not based on a single claim or feature
- Which product characteristics and features typically trigger medical device regulatory scope (e.g. diagnostics, clinical interpretation, closed-loop logic)
- How claims, UX wording, and product behavior interact in the FDA’s regulatory assessment
- Real-world examples of cutting-edge wellness and medical devices.
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?
The webinar will be live on February 2 at 4:30 p.m. CET
How can I register?
On-Demand – From Great Design to Great Code to Great Medical Devices: How to align IEC 62366-1 and IEC 62304
What is it about?
In many medtech projects, design, usability engineering, and software development start simultaneously but then gradually diverge. Programmed user interfaces may behave differently than planned, users may be unable to cope with workflows, and it may become nearly impossible to trace which decisions were relevant to safety later on. The consequences are rework, inefficient coordination, and uncertainty, which are often only visible during user tests or audits.
So, how can these unwanted silos be broken down? How can I ensure that excellent designs turn into outstanding code and, ultimately, great medical devices? This webinar will address these questions.
Dr. Benjamin Franz, Custom Medical’s Chief Growth & Innovation Officer, will demonstrate the issues that arise when IEC 62366-1 and IEC 62304 are processed in unintended silos and explain how to conceive them as a joint process.
In this webinar, you’ll learn:
- What great design, great code, and a great medical device actually are.
- Where typical breakpoints between design, usability, and software development arise and why even experienced teams are affected by them.
- How IEC 62366-1 and IEC 62304 can work together to help you avoid friction losses, extra work, and late surprises.
What is the language?
English
Who is hosting this webinar?
Dr. Benjamin Franz, CGIO
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?
On-Demand – Trace Me If You Can: How to Keep Track of Medical Device UI Design Decisions
What is it about?
Why was the button moved to the right? Why does the workflow look the way it does, and who decided on it? Questions like these arise in almost every development project. Without an rationale, endless discussions waste valuable time, and issues will arise during the audit.
In this webinar, Dr. Benjamin Franz, Custom Medical’s Chief Growth & Innovation Officer, will show you how to pragmatically and efficiently implement traceability in UI design. You will learn about the regulatory requirements of ISO 13485 and FDA QMSR; typical mistakes that occur in projects; and strategies that have been proven effective for documenting design decisions in a traceable, audit-proof manner.
In this webinar, you’ll learn:
- Which traceability regulatory requirements are absolutely essential
- 8 typical “traceability traps” from real projects — and how to avoid them
- 4 proven strategies for transparent decision-making and preventing unnecessary loops
What is the language?
English
Who is hosting this webinar?
Dr. Benjamin Franz, CGIO
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?
On-Demand – Your Perfect Timeline for Summative Evaluations & Human Factors Validation Testings
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?
Do you have questions or an idea for a webinar?
Are you uncertain about certain legal requirements or the implementation of usability engineering or testing? Please do not hesitate to contact us.