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3rd Forum Risk Management Medical Devices (Hybrid-Event)

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.

This year the Forum Risk Management Medical Devices is hybrid. It will therefore take place as planned on December 1 and 2 in Nuremberg. The speakers will be on site for lectures and personal exchange. A new feature is the possibility to participate online as an alternative. This means that anyone who does not want or is not allowed to attend due to current developments in connection with the corona pandemic can still secure valuable special knowledge. 

The regular price for online participation is 990 € net per person. Register by 15.11. and get the early bird price of 898 € net

IMPORTANT: Please let us know in the comment section of the registration form whether you wish to participate in the on-site event or online.Thank you very much!

3rd Forum Risk Management Medical Devices (Hybrid-Event)

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

    Welcoming address and introduction to the subject matter

    • Winfried Dietz, Dietz Consultants

    • The many challenges and opportunities presented by risk management for medical devices
    • Venturing to predict the future
    • The many challenges and opportunities presented by risk management for medical devices
    • Venturing to predict the future
  • 9:30 am

    Changes in process management at Dräger - Practical report on process management

    • Stefan Mersmann, Drägerwerk AG & Co. KGaA

    • Process-oriented organization
    • compliance
    • lean management principles
    • maturity model
    • process life cycle
    • change management
    • BP re-engineering
    • BPM office
    • BPM systems
    • agile BPM
    • Process-oriented organization
    • compliance
    • lean management principles
    • maturity model
    • process life cycle
    • change management
    • BP re-engineering
    • BPM office
    • BPM systems
    • agile BPM
  • 10:30 am

    Coffee break with stand-up snack

  • 11:00 am

    Software risk management

    • Matthias Hölzer-Klüpfel, Expert for development processes for medical devices

    • 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

    • The top 10 most common small mistakes and how to avoid them.
    • Why risk analyses are often too pessimistic, why and how this could be avoided.
    • How a notified body reads a risk analysis.
    • The top 10 most common small mistakes and how to avoid them.
    • Why risk analyses are often too pessimistic, why and how this could be avoided.
    • How a notified body reads a risk analysis.
  • 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

    • Dr. Boris Handorn, Produktkanzlei

    • 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

    The connections between, and “consistency” of, design and (manufacturing) process risk analyses

    • Winfried Dietz, Dietz Consultants

    • The requirements with regard to consistency
    • Proven consistency solutions with regard to design and manufacturing process analysis
    • Particular characteristics: Critical features and “special processes”
    • The requirements with regard to consistency
    • Proven consistency solutions with regard to design and manufacturing process analysis
    • Particular characteristics: Critical features and “special processes”
  • 10:00 am

    Requested

    • Christian Weckert, Ypsomed AG

  • 11:00 am

    Coffee break with stand-up snack

  • 11:30 am

    Adaptation to ISO 14971:2019 / Implementation of the changed requirements and interaction with interface processes

    • René Schmidt, Paul Hartmann AG

    • Evaluation of the influence of the amended standard within the overall context of the product life cycle process
    • Risk management challenge for simple products with a comprehensive intended use
    • Procedure for updating existing risk management files
    • Evaluation of the influence of the amended standard within the overall context of the product life cycle process
    • Risk management challenge for simple products with a comprehensive intended use
    • Procedure for updating existing risk management files
  • 12:30 pm

    Lunch together

  • 2:00 pm

    Setup and further development of risk management & FMEA at Balda Medical GmbH

    • Heike Ehlert, Balda Medical GmbH

  • 3:00 pm

    Clinical Workflow Know-How as a Critical Success Factor for Risk Management in the Development of Medical Devices

    • Prof. Dr. med. Clemens Bulitta, Ostbayerische Technische Hochschule Amberg-Weiden

    • What is workflow and how do I build up clinical workflow know-how?
    • How is workflow know how related to risk management and how can I anchor this in the development process?
    • What is and what role do "human factors" play as a "collective term" for complex psychological, cognitive and social influencing factors in socio-technical systems and human-machine systems?
    • What is workflow and how do I build up clinical workflow know-how?
    • How is workflow know how related to risk management and how can I anchor this in the development process?
    • What is and what role do "human factors" play as a "collective term" for complex psychological, cognitive and social influencing factors in socio-technical systems and human-machine systems?
  • 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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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 … more

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.

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Matthias Hölzer-Klüpfel

Expert for development processes for medical devices

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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Stefan Mersmann

Drägerwerk AG & Co. KGaA

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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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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René Schmidt

Paul Hartmann 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 … more

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.

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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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Heike Ehlert

Balda Medical GmbH

Head of Quality Planning

Head of Quality Planning

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Dr. Boris Handorn

Produktkanzlei

Dr. Boris Handorn specialises in comprehensive advice on medical devices law, drafting supply and quality assurance agreements in the Life Sciences sector and product liability law. In product liability law, he advises and represents companies on the … more

Dr. Boris Handorn specialises in comprehensive advice on medical devices law, drafting supply and quality assurance agreements in the Life Sciences sector and product liability law. In product liability law, he advises and represents companies on the coordination of recalls and communication with authorities, the defence of product liability claims and recovery of costs in the supply chain. He also specialises in contract drafting in cases of cooperation between Life Sciences companies, universities and research institutions.

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Exhibitor

Special conditions

  • As soon as you register more than one person from your company at the same time, we will gladly offer you a reduced event fee of 1.090 € plus VAT. (presence participation) or 798,00 € plus VAT. (online participation) per participant. Please give us an appropriate note when you register.

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

    Scope of services for online participation: 

    • Professional conference management
    • Presentations, pictures etc. in the protected download area (after the event)
    • Participation in the digital plenum
    • Participation certificate
    • Possibility to actively ask the speaker questions and participate in the discussion via an interactive tool
  • Requirements

  • Requirements

    • No special previous knowledge is required.

  • Special conditions

  • Cancellation conditions

  • Special conditions

    • As soon as you register more than one person from your company at the same time, we will gladly offer you a reduced event fee of 1.090 € plus VAT. (presence participation) or 798,00 € plus VAT. (online participation) per participant. Please give us an appropriate note when you register.

  • 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.