4th Forum Risk Management Medical Devices

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.

Scope of services

  • 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

Participant fee
The participation fee is 1.300,00€ (net)

31.05.2022 / 01.06.2022

Welcome coffee
FMEA for medical devices - the seven rules of success for D-FMEA Winfried Dietz, Dietz Consultants GmbH
  • System analysis for medical devices
  • Error analysis and risk reduction for medical devices
  • risk communication
Risk management thought out creatively - the application in focus Sascha Bettinghausen, Metecon GmbH
  • How can we do targeted risk management, without being unnecessarily distracted by templates?
  • How can creativity support us in risk management?
  • How can we play back efficiently transfer the results to risk management?
Coffee break
Block boundary diagrams for successful risk assessment of medical devices Winfried Dietz, Dietz Consultants GmbH
  • Define and document system boundaries
  • "Cut free" the system and thus identify the interfaces
  • Model the exchange of energies, signals and materials
Holistic riskmanagement: How does FMEA make us fit for the “VUCA world”? Prof. Dr. med. Clemens Bulitta, Ostbayerische Technische Hochschule Amberg-Weiden
  • How can FMEA-based riskmanagement help us deal with the current volatility, uncertainty, complexity and ambiguity in business models and markets?
  • How can this help us with scenario planning and prepare for unexpected contingencies?
  • How can we successfully leverage this approach to implement adaptability and agility and benefit from know-howand experience?
  • How does FMEA help us combine experimental thinking with an exploratory and iterative approach to holistic risk management?
interactive panel of experts
Coffee break
Risk minimization of medical devices throughdata-based knowledge generation Dr. Dirk Jödicke, Coaching & Prozessoptimierung
  • Once risks have been identified, how can they be minimized as quickly as possible and in a targeted manner?
  • How can complex interrelationships between influencing parameters be quantified?
  • How can mechanisms of action on complex medical devices be identified in a simple and reliable manner?
  • How can multiple quality criteria be optimized at the same time?
End of 1st day of the event
Guided tour of the historic old town
Stop at a traditional Franconian restaurant
Welcome coffee
The new approach: Monitoring and system response (MSR) for medical devices - detection measures when using the system Winfried Dietz, Dietz Consultants GmbH
  • How are detection measures mapped in the FMEA during use of the system through self-diagnosis?
  • Does this make the B values ​​(meaning of the consequences) variable?
  • Are new evaluation catalogs necessary for MSR-FMEA?
Liability for AI, IoT and robotics – is there an update coming (also) for medical product liability? Dr. Boris Handorn, Produktkanzlei
  • Product liability for software as a medical device (SaMD) and robotics according to the current legal situation
  • The proposals for a new European liability framework taking into account digital technologies
  • Possible impact on future development and liability risks of the industry
Coffee break
Apply parameter diagrams to identify the noise factors in the design and risk management process of medical devices Winfried Dietz, Dietz Consultants GmbH
  • The vertical flow (input/output) of the P diagram to the functional specification of the system
  • The horizontal flow of the P-diagram for the development of the noise and control factors of the medical device
  • The starting point of the P-diagram in the risk analysis of the medical device
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
  • How should the assessment of clinical risks correlate with risk assessment?
  • Which content is collected in the CER, and how does it feed into the RMR?
  • Which procedures are necessary?
  • What do you do with the data?
Apply parameter diagrams to identify the noise factors for manufacturing and assembly processes of medical devices Winfried Dietz, Dietz Consultants GmbH
  • The vertical flow (input/output) of the P diagram for the functional specification of the assembly/manufacturing process
  • The horizontal flow of the P-diagram to develop the noise and control factors of the assembly/manufacturing process
  • The starting point of the P-diagram in the risk analysis of the assembly/manufacturing process
end of the event
Speakers of the presentationsHere you can see the speakers who will give the presentations at the event.
Winfried Dietz

Dietz Consultants GmbH

Winfried Dietz is the founder and managing partner of DIETZ Consultants with subsidiaries in Asia and North America. He shoulders the responsibility of the FMEA business area development. Winfried Dietz has more than 30 years of practical experience, 25 years thereof as a consultant, trainer and coach. Other areas of interest and work include APQP, 8D, PPAP and functional safety and their interactions. Winfried Dietz is the organiser of the annual Osnabrück FMEA Forum.

Sascha Bettinghausen

Metecon GmbH

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.

Prof. Dr. med. Clemens Bulitta

Ostbayerische Technische Hochschule Amberg-Weiden

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.

Dr. Dirk Jödicke

Coaching & Prozessoptimierung

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.

Dr. Boris Handorn


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).

Stefan Bolleininger

be-on-Quality GmbH

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.”

About our hotel recommendationsFor our participants, a limited contingent of rooms is available at the indicated hotels at a preferential price. Please make the reservation yourself directly at the hotel in good time, referring to the event.
Park Inn by Radisson Nürnberg
Sandstraße 2-8, 90443 Nürnberg
+49 911 704 04 0
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