New challenges and innovative solutions
DIETZ Consultants’ 2nd Medical Devices Risk Management Forum is scheduled to take place in Nuremberg at the start of December. At its premiere last year, the event made its mark as the industry event for FMEA experts, interested developers, and manufacturers of medical devices. With top-class speakers, valuable information, and best practices on current developments, as well as solutions for new challenges. The 2nd Medical Devices Risk Management Forum will take place on December 03 and 04, 2019 in Nuremberg. “Integrating Risk Management into the Management System with ISO 13485:2016 and MDR 2017/745” is the title of the network meeting. Anyone who decides quickly and registers by September 30 can even take advantage of the attractive early bird discount and pay just €990.
Against a background of increasing demands on the quality of medical technology products, not least because healthcare remains one of the most critical sectors, DIETZ Consultants is tackling the future issues facing this sector. “It’s an exciting time for us, one that poses many challenges but that also offers great opportunities, especially in terms of digitalization,” says Winfried Dietz, CEO of DIETZ Consultants. As a globally active FMEA moderator, he knows that the importance of QM and risk management has steadily increased and that FMEA has become the most reliable tool. Risk management is indispensable during the development and production of medical devices, to avoid sources of error and minimize the risk for patients. However, as the first Medical Devices Forum confirmed, many questions remain open, especially for many SMEs. And this is exactly where this year’s network meeting comes in.
The motto of the Medical Devices Risk Management Forum is also reflected in the wide program of talks on a variety of medical device-related issues. Current and future challenges in the digital age will also be outlined, and innovative solutions and practical examples provided. The conference will be chaired by Winfried Dietz and Gregor Heilmaier.
First up in the exciting program of talks will be Dr. Christian Voß (OLYMPUS SURGICAL TECHNOLOGIES EUROPE), who will talk about FMEA as cultural change and answer questions about, for example, the path from FMEA reports to design management tools and successful integration in the process landscape. In the further course of the 2nd Medical Devices Risk Management Forum, Christian Weckert (Ypsomed AG) will present a practical report on the topic “From architecture-driven risk analysis to risk-driven architecture”. One focus of his report will be on functional safety in medical technology.
Further speakers on the program are Björn Schwarz (BAYOONET Aktiengesellschaft), with the Best Practice report “Integrating Risk Management into the Development Process”, Miriam Schuh (Reusch Rechtsanwaltsgesellschaft mbH), with her talk on “MDR Compliance from eHealth, Medical Apps, and Software”, and Dr. Ulrich Matern (Matern Consulting), answering the question “What can go wrong goes wrong – does that have to be? Relevance of clinical data for risk minimization and quality management (not only) in the context of MDR”.
A number of interactive elements and explanations from the host Winfried Dietz, who himself will speak on the topic “Risk management instead of crisis management for medical devices” will round off the forum. There will also be a panel of five recognized experts from various fields, discussing and answering questions on trends and developments in risk management for medical devices.