A person sitting on a desk, surveilled by two cameras, a hand with a stopwatch and another person's hands working on graphs. Symbolizing usability engineering.

Usability Engineering: Regulatory Requirements and Product Optimization

Workshop on November 12th, 2019 in Frankfurt

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Use Errors are a High Risk for Medical Devices

That’s why the new EU Medical Device Regulation (EU MDR) and the FDA demand a product design that is oriented on the user’s and patient’s safety. This is ensured by the manufacturer’s Usability Engineering. There is a close link to risk management and to clinical evaluation of medical devices. After all an user-specific optimized product is also an important competition advantage!

Benefit from Practical Experience

Our experts are experienced in the legal and standard-compliant implementation of usability engineering. In this practice-oriented workshop, they will discuss their experience and answer all of your questions.

A maximum of 50 participants are admitted in order to provide sufficient opportunities for discussion and direct contact with our experts. Register today!

Program

Workshop language will be German. A German program is available, too.

13:30Registration
14:00Welcome and Introduction
Dr. Thorsten Prinz, VDE
14:15Regulatory Requirements for Usability Engineering
Alfred Koch,
Legal Council, BAYOOMED, Darmstadt
Key questions and discussion:
– Regulatory requirements for usability engineering of medical devices in EU and USA
– Content of international standards: IEC 62366-1, AAMI HE75 and others
– Connection between usability engineering, risk management and clinical evaluation
14:45Discussion
15:00Coffee Break
15:30Usability Engineering in Practice
Dr. Michaela Kauer-Franz
Managing Director, Custom Medical, Darmstadt
Dipl.-Wirtsch.-Ing. Stefan Becher,
CEO, BAYOOMED, Darmstadt
Key questions and discussion:
– Starting with a plan until the report: How do I set up an efficient usability engineering process for my product?
– At which point of the product life cycle does the usability engineering play a role?
– Usability Engineering in practice: How does the exact procedure look like?
– Which special characteristics have to be considered with software?
16:00Discussion
16:15Networking
16:30End of Event

Program is subject to change without notice. Last updated: July 2019

Venue

VDE
Room “Ohm” (Ground Floor, V.00.024)
Stresemannallee 15
(Access via: Schreyerstraße)
60596 Frankfurt am Main

Participation

The participation fee is 150 EUR for non-members and 135 EUR for VDE members. Participation and refreshments during breaks are included, but not the cost of overnight accommodation or travel to and from the event. Cancellation conditions: free of charge up to 14 days before the date of the event, thereafter 100 percent of the participation fee as cancellation fee. The number of participants is limited to 50. The event will take place with a minimum of 15 participants. If the minimum number of participants is not reached the organizer reserves the right to cancel any booking on short notice. In this case all payed fees will be refunded. The organizer reserves the right to program changes without prior notice.
Photos are taken for media coverage on various platforms. If you do not want to be photographed, please let the staff present know.

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