3rd 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.
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.



The following exhibitors will be present

PLATO AG

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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 0,00€ (net)

01.12.2020 / 02.12.2020

08:00
Kaffee-Empfang mit Frühstücksimbiss
09:00
In Bearbeitung Winfried Dietz, Dietz Consultants
09:30
Prozessmanagement bei Dräger im Wandel - Praxisbericht zu Prozessmanagement Stefan Mersmann, Dräger Medical Deutschland GmbH
  • Prozess-orientierte Organisation
  • Compliance
  • Lean Management Prinzipien
  • Reifegradmodell, Prozess-Lebenszyklus
  • Change Management
  • BP Re-engineering
  • BPM Office
  • BPM Systeme
  • Agiles BPM
10:30
Kaffee-Pause mit Stehimbiss
11:00
Software-Risikomanagement Diplom-Physiker Matthas Hözer-Klüpfel, Matthias Hölzer-Klüpfel
  • Wie können Software-Ursachen für Risiken systematisch vermieden werden?
  • Wie spielen FMEA und FTA im Bereich der Software zusammen?
  • Wann ist der richtige Zeitpunkt für das Software-Risikomanagement, und wer kann das tun?
12:00
Die häufigsten Fehler beim Risikomanagement aus Sicht einer benannten Stelle Dr. Andreas Purde, TÜV SÜD Product Service GmbH
  • Die Top 10 der häufigsten kleinen Fehler und wie sie zu vermeiden sind.
  • Warum Risikoanalysen häufig zu pessimistisch sind, warum und wie das vermeidbar wäre.
  • Wie eine benannte Stelle eine Risikoanalyse liest.
13:00
Mittagsbuffet
14:30
Expertenrunde
15:30
Kaffeepause
16:00
Produktrisikomanagement in Zeiten des Wandels: Der (latente) Einfluss der digitalen Transformation auf die Produktsicherheit Christian Weckert, Ypsomed AG
  • Bei kontrolliertem Risiko mit komplexeren Produkten schneller an den Markt: Wie die ‚Quadratur des Kreises‘ gelingen kann
  • Änderungen an Legacy Produkten, oder: Was bei der ‚Operation am Offenen Herzen‘ schief gehen kann und wie man Risiken minimiert
  • Lernen von anderen: Konzepte von Scrum und DevOps ausserhalb der IT
17:00
Ende 1. Veranstaltungstag
Gemeinsamer Besuch Weihnachtsmarkt?
Gemeinsames Abendessen?
08:00
Kaffee-Empfang mit Frühstücksimbiss
09:00
In Bearbeitung Winfried Dietz, Dietz Consultants
10:00
In Bearbeitung
11:00
Kaffee-Pause mit Stehimbiss
11:30
Umstellung auf die ISO 14971:2019 / Implementierung der geänderten Anforderungen und Interaktion mit Schnittstellenprozessen René Schmidt, Paul Hartman AG
  • Bewertung des Einflusses der geänderten Norm auf den Gesamtkontext des Produkt Life Cycles Prozesses
  • Herausforderung für das Risikomanagement für einfache Produkte mit einer umfassenden Zweckbestimmung
  • Vorgehensweise zum Update bestehender Risiko Management Akten
12:30
Gemeinsames Mittagessen
14:00
In Bearbeitung
15:00
Klinisches Workflow Know How als kritischer Erfolgsfaktor für das Risikomanagement in der Entwicklung von Medizinprodukten Prof. Dr. med. Clemens Bulitta, Ostbayerische Technische Hochschule Amberg-Weiden
  • Was ist Workflow und wie baue ich klinisches Workflow-Know How auf?
  • Wie hängt Workflow Know How mit dem Risikomanagement zusammen und wie kann ich das im Entwicklungsprozess verankern?
  • Was ist und welche Rolle spielen "Human Factors" als "Sammelbegriff" für komplexe psychische, kognitive und soziale Einflussfaktoren in sozio-technischen Systemen und Mensch-Maschine-Systemen?
16:00
Ende der Veranstaltung
Speakers of the presentationsHere you can see the speakers who will give the presentations at the event.
Winfried Dietz

Dietz Consultants
www.dietz-consultants.com

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.

Stefan Mersmann

Dräger Medical Deutschland GmbH
https://www.draeger.com/de_de/Home

Stefan Mersmann is Head of Business Process Management at Drägerwerk AG & Co. KGaA in Lübeck. Dräger is a leading international medium-sized medical and safety technology company. Dräger products protect, support and save lives.Prior to this, Stefan Mersmann worked for Dräger in medical technology research and development for over 25 years, where he held various roles, including software engineer, project manager and department head. In his presentation, Stefan Mersmann will report on the “Lean Process Landscape” initiative, which aims to modernize process management in a highly regulated environment and make it fit for the future.

Diplom-Physiker Matthas Hözer-Klüpfel

Matthias Hölzer-Klüpfel
https://www.hoelzer-kluepfel.de/

Matthias Hölzer-Klüpfel studied physics at the University of Würzburg. Since 2002, he has worked as a developer, consultant, and project manager. He has completed numerous medical technology projects and has worked for both SME companies and large companies. Apart from his professional undertakings, he completed the master’s degree “IT in health care” in July 2009. Mr. Hölzer-Klüpfel is a cofounder of the association “ICPMSB e.V.”, which develops the principles for certification as a “Certified Professional for Medical Software”, and coauthor of the textbook “Basic Knowledge of Medical Software”. He also spearheads the expert committee “Software in Medical Technology” in the Association of German Engineers (Verein Deutscher Ingenieure, VDI). Since 2011, Mr. Hölzer-Klüpfel has been a freelance consultant for all questions concerning medical device development processes and has helped numerous companies develop software for their medical devices.

Prof. Dr. med. Clemens Bulitta

Ostbayerische Technische Hochschule Amberg-Weiden
https://www.oth-aw.de/

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.

René Schmidt

Paul Hartman AG

After studying communications and telecommunications engineering, he has worked for over 25 years in various areas with diverse responsibilities in the manufacture of medical devices. For the last 20 years, his focus has been increasingly shifting to quality management and regulatory affairs. He is currently the Senior Manager and Head of Regulatory Affairs Process Excellence and is responsible for the implementation and execution of risk management, usability engineering, management standards and regulations and labeling management.

Dr. Andreas Purde

TÜV SÜD Product Service GmbH

Andreas Purde studied electrical engineering and, after a brief foray into the semiconductor industry, he returned to the university to do his doctorate. He joined TÜV SÜD 15 years ago as a functional safety expert and auditor. He now heads the active medical devices division in Germany.

Christian Weckert

Ypsomed AG
https://www.ypsomed.com/de-DE/

As Regulatory Affairs Manager, Christian Weckert has been responsible for compliance with legal and normative requirements at the renowned Swiss medical technology company Ypsomed since 2019. Prior to that, he worked with partners from the pharmaceutical industry in risk management for combination products, such as injection pens and auto-injectors as well as insulin pump systems. Following his mechanical engineering studies, he moved to Switzerland in 2008, where he worked for Alstom (later General Electric) in the research and development of power plant turbines. Even before switching to medical technology, he specialized in risk management and FMEA there. Christian Weckert already gave a presentation on risk-based product development at the 2nd Medical Devices Risk Management Forum. Although increasing digitization and interconnection with the Internet of Things opens up many possibilities for new therapeutic approaches, it also presents manufacturers with enormous challenges. Risk management plays a key role in ensuring product safety and compliance with the high regulatory hurdles.

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
Address:
Bahnhofstraße 17-19, 90402 Nürnberg
Phone:
+49 30 2238 0233
Email:
reservierungen@nh-hotels.com
Web:
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