In medical technology, the importance of FMEA, QM and risk management is increasing. Agile product development and normative, legal or regulatory requirements such as the MDR present companies with ever new challenges. Against this background, the Forum Risk Management Medical Devices is the second major network meeting of DIETZ Consultants after the FMEA Forum - for FMEA experts, interested developers and manufacturers of medical devices.
Current Corona hygiene measures and rules apply.
- professional conference management
- presentations, pictures etc. in the protected download area (after the event)
- sufficient free space for exchange of experiences and knowledge transfer
- exhibitors on site
- certificate of participation
- lunch and catering during the coffee / tea breaks
- joint evening event on the 1st day of the event
31.05.2022 / 01.06.2022
- 08:00
- Welcome coffee
- 09:00
-
FMEA for medical devices - the seven rules of success for D-FMEA
Winfried Dietz, Dietz Consultants GmbH
- 09:30
-
Risk management thought out creatively - the application in focus
Sascha Bettinghausen, Metecon GmbH
- 10:30
-
Coffee break
- 11:00
-
Block boundary diagrams for successful risk assessment of medical devices
Winfried Dietz, Dietz Consultants GmbH
- 12:00
-
Holistic riskmanagement: How does FMEA make us fit for the “VUCA world”?
Prof. Clemens Bulitta, Ostbayerische Technische Hochschule Amberg-Weiden
- 13:00
- lunch
- 14:30
- interactive panel of experts
- 15:30
- Coffee break
- 16:00
-
Risk minimization of medical devices throughdata-based knowledge generation
Dr. Dirk Jödicke, Coaching & Prozessoptimierung
- 17:00
- End of 1st day of the event
- Guided tour of the historic old town
- Stop at a traditional Franconian restaurant
- 08:00
- Welcome coffee
- 09:00
-
The new approach: Monitoring and system response (MSR) for medical devices - detection measures when using the system
Winfried Dietz, Dietz Consultants GmbH
- 10:00
-
Liability for AI, IoT and robotics – is there an update coming (also) for medical product liability?
Dr. Boris Handorn, Produktkanzlei
- 11:00
- Coffee break
- 11:30
-
Apply parameter diagrams to identify the noise factors in the design and risk management process of medical devices
Winfried Dietz, Dietz Consultants GmbH
- 12:30
- lunch
- 14:00
-
Risk and benefit in CER, RMR – How is the benefit-risk assessment graded and what factors need to be assessed
Stefan Bolleininger, be-on-Quality GmbH
- 15:00
-
Apply parameter diagrams to identify the noise factors for manufacturing and assembly processes of medical devices
Winfried Dietz, Dietz Consultants GmbH
- 16:00
- end of the event
- Company
- be-on-Quality GmbH
- Information
- Stefan Bolleininger is the founder of be-on-Quality GmbH and is an independent consultant for risk management, quality management, regulatory affairs and development processes. His primary focus is on providing quality support for development projects by medical device manufacturers during the CE certification or FDA approval processes and supporting them through audits, assessments, and inspections.
He is a lecturer at the TH Nuremberg in the areaof “Risk management and usability for medical devices and medical networks,”and is a member of the association “International Certified Professional for Medical Software (ICPMSB e.V.)” and of the VDI expert committee “Quality assurance for software in medical technology.”
- Company
- Coaching & Prozessoptimierung
- Information
- Dirk Jödicke studied chemistry in Bochum and Oviedo (Spain). After taking a doctorate in Organic Chemistry, he began his professional career in the sheet glass industry. In laboratories, pilot plants and production facilities in this industry, he worked on innovative glass and plastic composite systems, thin semiconductor films, lithium-ion conductive polymers, electrochromics, photochromics and other systems to exploit variable properties in glass for architectural and automotive applications. Numerous inventions subsequently led to the successful market launch of so-called intelligent windows with variable light transmission. Dirk Jödicke was Head of Research and Development and Head of Quality Assurance, and as a Six Sigma Master Black Belt he is now a freelance consultant for Six Sigma in statistical data analysis, statistical design of experiment, and process optimization.
- Company
- Dietz Consultants GmbH
- Information
- Winfried Dietz is the founder and managing partner of DIETZ Consultants GmbH, an international consulting company with subsidiaries in China and India. Under his leadership, the company group has developed into a leading provider in the field of quality and risk management. DIETZ Consultants supports leading OEMs and Tier-1s in the automotive industry worldwide as well as clients in the aerospace, defense, engineering and manufacturing technology sectors. DIETZ Consultants' FMEA forums are important events in the annual cycle for a global community of experts to exchange expertise and further develop methods.
- Company
- Metecon GmbH
- Information
- Sascha Bettinghausen now looks back on several years of experience as a risk manager and usability specialist in various areas of medical technology. Starting with the development of training simulators in the medical field as a software engineer, Mr. Bettinghausen worked as a system and usability engineer in the field of active medical devices before joining Metecon GmbH as a consultant and trainer in the field of regulatory affairs. Since 2017, Mr. Bettinghausen has also been a member of the usability standardization committee and regularly gives training courses and trainings in the field of design control, risk management and usability engineering.
- Company
- Ostbayerische Technische Hochschule Amberg-Weiden
- Information
Prof. Dr. Bulitta has extensive international experience and knowledge in clinical medicine as well as in the healthcare and medical technology industries. After graduating from the classical secondary school in Erlangen, he went on to study human medicine in Heidelberg, the USA and Switzerland. In 1995, he received his doctorate from the Faculty of Medicine at the University of Heidelberg. This was followed by further surgical training at the Department of Trauma Surgery of the University Hospital in Essen and the Department of General Surgery of the University Hospital in Mainz.
From 1999 to 2001, Prof. Dr. Bulitta was a research fellow at Massachusetts General Hospital – which is affiliated with Harvard University – in Boston, USA, on a scholarship from the German Research Foundation. At the beginning of 2001, he joined the Siemens AG Healthcare Sector. There, he initially worked for several years as a healthcare sector consultant for Siemens Healthcare. He subsequently held various management positions at Siemens Healthcare, including in the business development, clinical marketing and product management departments for the business field of surgery. In his last position at Siemens, beginning in 2010, he was responsible for worldwide project and partner management for angiography systems in the operating room, also referred to as hybrid ORs. Since September 1, 2012, he has held the professorship for “Diagnostic Systems and Medical Technology Management” at OTH – Technical University of Applied Sciences (Ostbayerische Technische Hochschule Amberg-Weiden).
Since the summer semester of 2014, Prof. Dr. Bulitta has been the Director of Studies and Academic Advisor for the bachelor’s degree program in medical technology. Since January 2015, he has been head of the newly founded Institute for Medical Technology at OTH – Technical University of Applied Sciences and since 01.10.2021 Professor Bulitta is the President of the Technical University.
- Company
- Produktkanzlei
- Information
- Dr. Boris Handorn is an Augsburg-based lawyer, who specializes in comprehensive advice on medical devices law, drafting supply and quality assurance agreements in the Life Sciences sector, and product liability law. He studied Law at the Free University of Berlin and Industrial Engineering at the Technical University of Berlin. Dr. Handorn is a lecturer at the Ludwig-Maximilians University Munich, a member of the scientific advisory board of the Research Center for Medical Device Law at the University of Augsburg, and a member of the Law working group of the German Medical Technology Association (BVMed).
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- Sandstraße 2-8, 90443 Nürnberg
- Phone:
- +49 911 704 04 0
- Email:
- events.nuernberg@parkinn.com
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