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3rd Forum Risk Management Medical Devices

The importance of FMEA, QM and risk management is increasing in medical technology. Agile product development and normative, legal or official requirements such as MDR are constantly presenting companies with new challenges. Because of that, the Forum Risk Management Medical Devices is, after the FMEA Forum, the second large network meeting of DIETZ Consultants - for FMEA experts, interested developers and manufacturers of medical devices.

3rd Forum Risk Management Medical Devices

Start:
01.12.2020 — 9:00 am

End:
02.12.2020 — 4:00 pm

Venue:
Nürnberg
Hotel NH Collection Nürnberg City

Language:
German
Sign up Print

Registration also via:

akademie@dietz-consultants.com
Phone: +49 5407 81 86 40
Fax: +49 5407 81 86 44

Agenda

Tuesday 01.12.2020
  • 8:00 am

    Coffee reception with breakfast snack

  • 9:00 am

    In process

    • Winfried Dietz, Dietz Consultants

  • 9:30 am

    Business Process Management

    • Stefan Mersmann, Dräger Medical

  • 10:30 am

    Coffee break with stand-up snack

  • 11:00 am

    Software risk management

    • Matthias Hölzer-Klüpfel,

    • How can risks caused by software be systematically avoided?
    • How do FMEA and FTA collaborate in the field of software?
    • What is the right moment for software risk management, and who can do it?
    • How can risks caused by software be systematically avoided?
    • How do FMEA and FTA collaborate in the field of software?
    • What is the right moment for software risk management, and who can do it?
  • 12:00 pm

    The most common risk management errors from the perspective of a notified body

    • Dr. Andreas Purde, TÜV Süd

  • 1:00 pm

    Lunch buffet

  • 2:30 pm

    Expert panel

    • Winfried Dietz, Dietz Consultants

    Four experts are available for questions and discussions!

    Four experts are available for questions and discussions!

  • 3:30 pm

    Coffee break

  • 4:00 pm

    Product risk management in times of change: The digital transformation’s (latent) influence on product safety

    • Christian Weckert, Ypsomed AG

    • Getting more complex products to market faster while keeping risks under control: How to ‘square the circle’
    • Changes to legacy products, or: What can go wrong with ‘open heart surgery’ and how to minimize risks
    • Learning from others: Scrum and DevOps concepts outside of IT
    • Getting more complex products to market faster while keeping risks under control: How to ‘square the circle’
    • Changes to legacy products, or: What can go wrong with ‘open heart surgery’ and how to minimize risks
    • Learning from others: Scrum and DevOps concepts outside of IT
  • 5:00 pm

    End of Day 1 of the event

Wednesday 02.12.2020
  • 8:00 am

    Coffee reception with breakfast snack

  • 9:00 am

    In process

    • Winfried Dietz, Dietz Consultants

  • 10:00 am

    Design FMEA: Two years on – challenges, solutions, successes

    • Katharine Meierholz, B. Braun Avitum

  • 11:00 am

    Coffee break with stand-up snack

  • 11:30 am

    In process

    • René Schmidt, Paul Hartmann AG

  • 12:30 pm

    Lunch together

  • 2:00 pm

    Practice report D-FMEA in electronics development

    • Benjamin Ziebarth, Olympus Surgical Technologies Europe

  • 3:00 pm

    In process

  • 4:00 pm

    End of event

Speaker

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, … more

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.

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Christian Weckert

Ypsomed AG

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 … more

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.

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Benjamin Ziebarth

Olympus Surgical Technologies Europe

Benjamin Ziebarth is Product Quality Manager at Olympus Surgical Technologies Europe in Berlin. He is responsible for quality tasks in development projects with a focus on design verification and FMEA moderation. Previously, Benjamin Ziebarth managed … more

Benjamin Ziebarth is Product Quality Manager at Olympus Surgical Technologies Europe in Berlin. He is responsible for quality tasks in development projects with a focus on design verification and FMEA moderation. Previously, Benjamin Ziebarth managed various product developments and design transfers with Asian contract manufacturing in the telecommunications industry. His technical focus is on electronics development, process safety and quality controlling.

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Matthias Hölzer-Klüpfel

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 … more

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.

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Dr. Andreas Purde

TÜV Süd

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 … more

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.

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Stefan Mersmann

Dräger Medical

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 … more

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.

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Exhibitor

Participation fee

The participation fee amounts to 1.300,00 €plus statutory VAT.

990,00 € Preferential price until 01.09.2020

Group price from 2 People: 1.100,00 €.

Special conditions

  • We will gladly offer you a discount on the seminar fee if we get registration of more than one person from the same company. A seminar fee of 1,100.00 € plus VAT is invoiced per participant. Please inform us accordingly. Thank you!

  • Early bird discount: For registration until 30.09.2019 we grant you a reduced event fee of 990 € net / participant!

Cancellation conditions

  • Dietz Consultants reserves the right to cancel the seminar in the case of certain unexpected events. The participants will be notified in time. A refund, not higher than the participation fee, is possible.
    Courses cancelled up to two weeks before their planned date are eligible for a full refund; thereafter the full fee will be charged. It is possible to transfer the registration to another person for the same course dates.

Event addresses

Conference Location

Hotel NH Collection Nürnberg City

Bahnhofstraße 17-19
90402 Nürnberg

Tel.: +49 911 99990
E-Mail: nhcollectionnuernbergcity@nh-hotels.com
Website: NH Collection Nürnberg City

For our participants there is a limited number of rooms available in the hotel at a preferential price.
Please make the reservation yourself in time directly at the hotel, referring to Dietz Medical Devices Forum. 

Tagungsort

Hotel NH Collection Nürnberg City

Bahnhofstraße 17-19
90402 Nürnberg

Tel.: +49 911 99990
E-Mail: nhcollectionnuernbergcity@nh-hotels.com
Website: NH Collection Nürnberg City

For our participants there is a limited number of rooms available in the hotel at a preferential price.
Please make the reservation yourself in time directly at the hotel, referring to Dietz Medical Devices Forum. 

Hotel recommendations

Hotel NH Collection Nürnberg City

Bahnhofstraße 17-19
90402 Nürnberg

Tel.: +49 911 99990
E-Mail: nhcollectionnuernbergcity@nh-hotels.com
Website: NH Collection Nürnberg City

For our participants there is a limited number of rooms available in the hotel at a preferential price.
Please make the reservation yourself in time directly at the hotel, referring to Dietz Medical Devices Forum. 

  • Specification

  • Specification

    • professional conference management
    • Presentations, pictures etc. in the protected download area (after the event)
    • sufficient open space for exchange of experience and knowledge transfer
    • Exhibitors on site
    • participation certificate
    • Meals and catering in the coffee / tea breaks
    • joint evening event on the 1st day of the event
  • Requirements

  • Requirements

    • No special previous knowledge is required.

  • Participation fee

  • Special conditions

  • Cancellation conditions

  • Participation fee

    The participation fee amounts to 1.300,00 €plus statutory VAT.

    990,00 € Preferential price until 01.09.2020

    Group price from 2 People amounts to 1.100,00 €plus statutory VAT.

  • Special conditions

    • We will gladly offer you a discount on the seminar fee if we get registration of more than one person from the same company. A seminar fee of 1,100.00 € plus VAT is invoiced per participant. Please inform us accordingly. Thank you!

    • Early bird discount: For registration until 30.09.2019 we grant you a reduced event fee of 990 € net / participant!

  • Cancellation conditions

    • Dietz Consultants reserves the right to cancel the seminar in the case of certain unexpected events. The participants will be notified in time. A refund, not higher than the participation fee, is possible.
      Courses cancelled up to two weeks before their planned date are eligible for a full refund; thereafter the full fee will be charged. It is possible to transfer the registration to another person for the same course dates.