Risk management in times of agile change

DIETZ Consultants organised the 1st forum on risk management of medical products.

As a consulting and service company for quality and risk management, DIETZ Consultants is not just well-known in the automobile industry and has also been recognised well beyond Germany for a long time now. The company is now expanding its range under the motto "Risk management in time of change: MDR, DIN EN ISO 13485, ICE 62366". The 1st forum on risk management of medical products is held in Nuremberg from the 13th to 14th June 2018. The number of participants is limited. Those who want to be there can still register online. A few seats are still available.

What is the effect of MDR, DIN EN ISO 13485, ICE 62366?

The first forum of its type is addressed to all those engaged in the medical products sector with the topic of risk management and especially FMEA. The aim of Dietz Consultants is how to employ the world's leading Osnabrück FMEA forum to set up a strong network for the automobile industry and other industries and how to exchange ideas. One question, which is in focus here, is the one for the specific challenges in the industry, which is still in flux. What should be considered in the future? And how can known and emerging risks be best managed in the digital age?

Risk management gains importance in times of agile product development

"Our experience shows that risk management and FMEA continuously gain importance in times of increasing agile product development even in medicine. FMEA lends projects security and stability at a very early stage. Everybody profits from that in the end, from the manufacturer to the customer and across all steps of the value chain", says Winfried Dietz. As the Managing Director of DIETZ Consultants, at the 1st forum on risk management of medical products, not only is he the host, but he will also speak about the normative and regulatory requirements for risk management and also present opportunities and Best Practice solutions. With he three decades of experience as trainer, moderator and consultant for risk management, especially in the industrial products, automobile and medical technology sectors, he shares his rules for success and tools in the FMEA application for medical products. And he answers the question, what exactly changes for risk management in agile development?

Lecturers are proven experts for FMEA in medical products

The lecturers in Nuremberg include proven experts and industry insiders from different areas of production of high-value medical products. Among others, Franz-Josef Schmitt from Fresenius Medical Care Deutschland GmbH looks with the participants into the practice of development and manufacture of dialysis machines with the implementation of risk management. The specialist for surgery, Dr. med. Dipl.-Eng. Helmut Mückter of Dr. Mückter MedTech Consult, talks about risk analysis in the clinical application of medical products in the fringe range of FMEA. And Matthias Loch of Otto Bock HealthCare GmbH speaks about risk management as per ISO 14971, including link to the FMEA. Other topics include MDR and the clinical evaluation as a real challenge as well as the new standards ISO 13485, 14971, European Medical Device Regulation (E-MDR) and the accompanying, profitable implementation.

The 1st forum on risk management of medical products shall take place on Wednesday, 13th and Thursday, 14th June 2018 at Hotel NH Collection Nuremberg City, Bahnhofstraße 17-19, 90402 Nuremberg. The registration fee is 1,300 Euro per person. If a company is sending more than one person, the amount is reduced to 1,100 Euro. The registration fee includes detailed training documents, a certificate of participation and food as well as a joint evening soiree for networking. More information: DIETZ Consultants, Dipl. Eng. Winfried K. Dietz, Telephone +49 5407 818640,