Workshop on September 11, 2019 in Frankfurt
The new EU Medical Device Regulation (EU MDR) requires manufacturers to develop and manufacture software according to the “principles of development life cycle”. The relevant standard in this context is the IEC 62304, which is currently under revision. Moreover, the IEC 82304-1 standard completes the applicability by, among other things, extending its focus to the life cycle of health software and stand-alone software (medical apps).
Focus on Implementation of Regulatory Requirements
Our speakers are experts in the fields of legal and norm-compliant development and production of medical software. In this practice-oriented workshop, they will discuss with you the implementation of the repective standards.
A maximum of 40 participants are admitted to enable sufficient discussion opportunities and direct contact with our experts. Register today!
Workshop language will be German. A German program is available, too.
|14:00||Welcome and Introduction|
Dr. Thorsten Prinz, VDE
|14:15||Life Cycle Processes for the Development of Medical Software|
Dipl.-Ing. Hans Wenner
Owner Engineering Office Wenner, Rüsselsheim
– What does software life cycle mean?
– Structure and main contents of IEC 62304 (software safety classification, software development processes, software maintenance and problem solving)
– Outlook on the new IEC 62304 (Edition 2)
– Requirements of IEC 82304-1 for health software
|15:30||Implementation of Life Cycle Processes in Development – From Theory to Implementation|
Dipl.-Ing. Sven Wittorf
Managing Director, Medsoto GmbH, Pfungstadt
– How can I work with the standard in a structured way?
– Which requirements are particularly difficult to implement?
– Requirements, Traceability, Test planning, proof of conformity – how does it work?
– How and where can tools support me?
|16:30||End of the Event|
Program is subject to change without notice. Last updated: May 2019
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 40. 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.