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2nd Forum Risk Management Medical Devices

Integrating Risk Management into the Management System with ISO 13485:2016 and MDR 2017/745 - New Challenges, Innovative Solutions

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.

Early bird discount until 30.09.2019 - participation fee of 990 Euro. 

2nd Forum Risk Management Medical Devices

Start:
03.12.2019 — 9:00 am

End:
04.12.2019 — 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 03.12.2019
  • 8:00 am

    Coffee reception with breakfast snack

    • Registration of participants
    • Delivery of the conference documents
    • Registration of participants
    • Delivery of the conference documents
  • 9:00 am

    Risk Management for Medical Devices in Times of Agility

    • Winfried Dietz, Dietz Consultants

    • Success factor: Preventive risk management
    • Examples: best practice
    • Success factor: Preventive risk management
    • Examples: best practice
  • 9:30 am

    FMEA as cultural change

    • Dr. Christian Voß, OLYMPUS SURGICAL TECHNOLOGIES EUROPE

    • From FMEA Report to Design Management Tool
    • Integration into the process landscape
    • Practice FMEA successfully: Working at the right level of abstraction
    • From FMEA Report to Design Management Tool
    • Integration into the process landscape
    • Practice FMEA successfully: Working at the right level of abstraction
  • 10:30 am

    Coffee break with snacks

  • 11:00 am

    From architecture-driven risk analysis to risk-driven architecture. A practical report.

    • Christian Weckert, Ypsomed AG

    • Functional Safety in Medical Technology: A Classification
    • Identifying key performance characteristics and formulating safety objectives
    • Safeguarding the security objectives by means of risk-based architecture and suitable methods
    • Functional Safety in Medical Technology: A Classification
    • Identifying key performance characteristics and formulating safety objectives
    • Safeguarding the security objectives by means of risk-based architecture and suitable methods
  • 12:00 pm

    Integrating Risk Management into the Development Process - Best Practice

    • Björn Schwarz, BAYOONET AG

    • Combining risk management and development processes is a challenge
    • Where are the starting points for implementing such integration?
    • Practical examples of process interfaces
    • Combining risk management and development processes is a challenge
    • Where are the starting points for implementing such integration?
    • Practical examples of process interfaces
  • 12:30 pm

    Lunch

  • 2:30 pm

    Expert panel: Developments and trends in risk management for medical devices

    • Winfried Dietz, Dietz Consultants

    • Gregor Heilmaier, Heilmaier und Heilmaier GmbH

    Moderators: Winfried Dietz and Gregor Heilmaier
    5 experts are available for questions and discussion!

    Moderators: Winfried Dietz and Gregor Heilmaier
    5 experts are available for questions and discussion!

  • 3:30 pm

    Coffee break with snacks

  • 4:00 pm

    Lecture still in planning

  • 5:00 pm

    End of the 1st event day

  • 7:30 pm

    Joint visit to the Nuremberg Christmas Market

Wednesday 04.12.2019
  • 8:00 am

    Coffee reception with breakfast snacks

  • 9:00 am

    Risk management instead of crisis management for medical devices

    • Winfried Dietz, Dietz Consultants

    • Success rules for FMEA
    • practical example
    • Success rules for FMEA
    • practical example
  • 10:00 am

    MDR Compliance from eHealth, Medical Apps and Software

    • Miriam Schuh, Reusch Rechtsanwaltsgesellschaft mbH

    • Software as medical devices in the sense of MDR
    • Special Features of Medical Apps - Classification Questions
    • Safety and liability risks for networked medical devices
    • Cybersecurity in Risk Management
    • Software as medical devices in the sense of MDR
    • Special Features of Medical Apps - Classification Questions
    • Safety and liability risks for networked medical devices
    • Cybersecurity in Risk Management
  • 11:00 am

    Coffee break with snacks

  • 11:30 am

    In planning

  • 12:30 pm

    Lunch

  • 2:00 pm

    "What can go wrong goes wrong" - does that have to be? Relevance of clinical data for risk minimization and quality management (not only) in the context of MDR

    • PD Dr. med. Ulrich Matern, Matern Consulting

    • clinical trials
    • clinical evaluation
    • usability
    • clinical trials
    • clinical evaluation
    • usability
  • 3:00 pm

    The first cut is the deepest - How risk management interfaces can be seams

    • Sven Wittorf, Medsoto GmbH

    • What are the "big issues" in the development of medical devices?
    • How do they relate to risk management?
    • Where are the thematic interfaces between the topics?
    • What are the "big issues" in the development of medical devices?
    • How do they relate to risk management?
    • Where are the thematic interfaces between the topics?
  • 4:00 pm

    End of the 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

Christian Weckert looks back on several years of experience as a mechanical engineer and risk manager. As a student involved in the development of the Airbus A380, he moved to Switzerland in 2008, where he worked for Alstom in turbine development. … more

Christian Weckert looks back on several years of experience as a mechanical engineer and risk manager. As a student involved in the development of the Airbus A380, he moved to Switzerland in 2008, where he worked for Alstom in turbine development. There he assumed responsibility for risk management and FMEA. In 2016 he moved to medical technology at the renowned family-owned company Ypsomed AG in Burgdorf near Bern. He is responsible for the risk management of injection systems such as pumps and pens, also in cooperation with international pharmaceutical partners. Digitalisation and networking with the Internet of Things opens the door to new exciting products, but also poses some challenges for risk management together with MDR.

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Miriam Schuh

Reusch Rechtsanwaltsgesellschaft mbH

Expert, among others, in the fields of medical device law/medical law, pharmaceutical law, cosmetics law, international product liability law. Project Medical Device Law: MDR Compliance Support. Regular
Publications on medical device law in … more

Expert, among others, in the fields of medical device law/medical law, pharmaceutical law, cosmetics law, international product liability law. Project Medical Device Law: MDR Compliance Support. Regular
Publications on medical device law in "medizin&technik", Konradin Verlag: Leinfelden-Echterdingen and in "DeviceMed", Vogel Business Media GmbH: Würzburg.

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Sven Wittorf

Medsoto GmbH

Sven Wittorf is a specialist for medical software and since 2012 managing partner of Medsoto GmbH, which manufactures software tools for medical technology manufacturers and accompanies their introduction. In addition, he is trainer for the … more

Sven Wittorf is a specialist for medical software and since 2012 managing partner of Medsoto GmbH, which manufactures software tools for medical technology manufacturers and accompanies their introduction. In addition, he is trainer for the certification program "Certified Professional for Medical Software" and co-author of the VDI guideline 5702 "Medical Devices-Software - Medical SPICE process assessment model" and the book "Basic knowledge medical software", which was published by dpunkt.verlag.

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Björn Schwarz

BAYOONET AG

Björn Schwarz is a medical device engineer specializing in medical software and clinical processes. For several years he has been a freelance lecturer for various universities and the State Medical Association of Hesse. After positions in research … more

Björn Schwarz is a medical device engineer specializing in medical software and clinical processes. For several years he has been a freelance lecturer for various universities and the State Medical Association of Hesse. After positions in research and teaching and clinical IT, he is responsible for medical software development and risk management projects for the approval of medical devices at BAYOOMED.

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Dr. Christian Voß

OLYMPUS SURGICAL TECHNOLOGIES EUROPE

Dr. Christian Voß received his doctorate from the Technical University of Hamburg-Harburg in the field of microsystems technology and medical technology. He then worked in clinical research at the Berufsgenossenschaftlichen Unfallkrankenhaus Boberg. … more

Dr. Christian Voß received his doctorate from the Technical University of Hamburg-Harburg in the field of microsystems technology and medical technology. He then worked in clinical research at the Berufsgenossenschaftlichen Unfallkrankenhaus Boberg. For five years now he has been working as a quality engineer at Olympus Surgical Technologies Europe in Hamburg, where he has been working intensively on the methodology and introduction of FMEA for two years. He is currently working on standardizing the methodology across all European location.

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PD Dr. med. Ulrich Matern

Matern Consulting

Dr. Matern is a specialist in surgery and a lecturer in the field of medical technology. Before becoming a partner and consultant at Matern Consulting in 2014, he was manager for clinical and medical issues at Stryker in Freiburg.

His expertise … more

Dr. Matern is a specialist in surgery and a lecturer in the field of medical technology. Before becoming a partner and consultant at Matern Consulting in 2014, he was manager for clinical and medical issues at Stryker in Freiburg.

His expertise includes clinical trials and preclinical testing, research and development, and quality control for new products. He participates in the development of marketing and sales measures and assesses usability and other important aspects in the context of product development.

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Participation fee

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

990,00 € Preferential price until 30.09.2019

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

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

Hotel recommendations

Novotel Nürnberg Centre Ville

Bahnhofstraße 12
90402 Nürnberg

Tel: +49 - 911-300 35-808
E-Mail: banquet2@novo-nuernberg.de
Website: Novotel Nürnberg Centre Ville 

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

  • Content

  • Specification

  • Content

    Motto: Integrating Risk Management into the Management System with ISO 13485:2016 and MDR 2017/745 - New Challenges, Innovative Solutions

  • 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

  • Related events

  • Participation fee

  • Special conditions

  • Cancellation conditions

  • Participation fee

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

    990,00 € Preferential price until 30.09.2019

  • 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.