Risk management for medical devices in times of increasing agility and MDR
The 2nd Forum Risk Management Medical Devices of DIETZ Consultants is about to start. With Stefan Bolleininger from be-on-Quality, another expert from practice could be won as a speaker. MDR State of Play" is the title of the lecture of the lecturer of the TH Nuremberg for "Usability and Risk Management for Medical Devices and Medical Networks" on the first afternoon of the two-day forum. Specifically, he will address the question of which boundary conditions are specified by the MDR and where there is still room for maneuver.
The 2nd Forum Risk Management Medical Devices will take place on December 3 and 4, 2019 in Nuremberg. The continuation of the successful network meeting of FMEA experts, interested developers and manufacturers of medical devices is themed "Integrating risk management into the management system with ISO 13485:2016 and MDR 2017/745". Those who still want to attend should hurry.
At its premiere last year, the forum proved to be an industry meeting and networking platform for the exchange of know-how and expertise. And this time, too, numerous experts from the most diverse areas of medical technology will be there. Participants can look forward to many exciting topics and very different facets of medical devices - from current and future challenges in the digital age to innovative approaches to solutions and successful practical examples. Speakers include Dr. Christian Voß (OLYMPUS SURGICAL TECHNOLOGIES EUROPE) with the topic of FMEA as a cultural change, Christian Weckert (Ypsomed AG) with a practical report "From architecture-driven risk analysis to risk-driven architecture", Björn Schwarz (BAYOONET Aktiengesellschaft) with the topic "Integrating risk management into the development process", Miriam Schuh (Reusch Rechtsanwaltsgesellschaft mbH) with her presentation on "MDR compliance of eHealth, medical apps and software" and PD Dr. med. Ulrich Matern (Matern Consulting) with the answer to the question "What can go wrong does go wrong - does it have to?". Sven Wittorf from Medsoto will conclude the event on December 4, 2019, with his presentation on "How risk management interfaces can become seams." In addition, interactive elements such as a panel of experts moderated by host Winfried Dietz with five recognized experts on the topic of developments and trends in risk management for medical devices will round out the forum.
The participation fee is 1,300 euros. The group rate for two or more people from one company is 1,100 euros. Info and registration here!