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.
Participant fee
The participation fee is 1.300,00€ (net)Early bird discount: If you register by 30. September 2021, we will grant you a discounted event fee.The participation fee for early bookers is 990,00€ (net)

30.11.2021 / 01.12.2021

In Bearbeitung Winfried Dietz, Dietz Consultants
Risikomanagement kreativ gedacht – die Anwendung im Fokus Sascha Bettinghausen, Metecon GmbH
Kaffee-Pause mit Stehimbiss
Ganzheitliches Risikomanagement: Wie macht uns die FMEA fit für die „VUCA-Welt“? Prof. Dr. med. Clemens Bulitta, Ostbayerische Technische Hochschule Amberg-Weiden
  • Wie kann uns ein FMEA basiertes Risikomanagement helfen mit der aktuellen Volatilität, Unsicherheit, Komplexität und Mehrdeutigkeit in Geschäftsmodellen und Märkten umzugehen?
  • Wie kann uns das helfen, in Szenarien zu planen und uns auf unvorhergesehene Eventualitäten vorzubereiten?
  • Wie gelingt es Anpassungsfähigkeit und Agilität dadurch erfolgreich umzusetzen und von Know-How und Erfahrung zu profitieren?
  • Wie hilft uns die FMEA, experimentelles Denken und ein exploratives, iteratives Vorgehen zum ganzheitlichen Risikomanagement zu verbinden?
In Bearbeitung
In Bearbeitung
Ende 1. Veranstaltungstag
Gemeinsamer Besuch Weihnachtsmarkt
Gemeinsames Abendessen im Gasthof Pillhofer
Kaffee-Empfang mit Frühstücksimbiss
In Bearbeitung Winfried Dietz, Dietz Consultants
In Bearbeitung Boris Handorn, Produktkanzlei
Kaffeepause mit Stehimbiss
In Bearbeitung
Gemeinsames Mittagessen
In Bearbeitung
In Bearbeitung
Ende der Veranstaltung
Speakers of the presentationsHere you can see the speakers who will give the presentations at the event.
Winfried Dietz

Dietz Consultants

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.

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).

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.
NH Collection Nürnberg City
Bahnhofstraße 17-19, 90402 Nürnberg
+49 30 2238 0233
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