Tuttlingen – Last year, MedicalMountains GmbH held a seminar for the first time, which was aimed exclusively at consultants who support companies in the area of MDR. The general conclusion of the participants was the desire for more, above all for more professional exchange and discussion. In 2022 there will now be a complete seminar series "Updates for consultants: Current status of the implementation of the EU-MDR" - exclusively and exclusively for consultants.
Each individual seminar will be structured in such a way that current topics relating to the MDR can be dealt with, but above all the focus will be on discussion and mutual exchange. It is expressly desired that the participants contribute to the seminar. Participants can also communicate their desired topics, questions and suggestions in advance.
What else does Hans-Heiner Junker, Regulatory Expert for Medical Devices and speaker of the seminar series, have to say about this special training concept? Julia Lange from MedicalMountains GmbH interviewed him:
Which topics will be the focus of your seminar series?
The MDR has been around for around 5 years now. One might think that all the topics have already been put on the table and discussed. However, one must not forget that even after almost 30 years of MDD, questions remained unanswered until the end. Therefore, over time, the exchange has always been important. The seminar is designed in such a way that regulatory topics are only briefly presented and then deepened in an open discussion with and between the participants. We present points that are of particular importance for manufacturers now in the initial phase of the MDR. These are, for example, classifications, conformity assessment procedures, technical documentation, the quality management system and EUDAMED.
Why are the main focus of your seminar series on discussion and mutual exchange?
In seminars, the participants are mostly in the passive role of the listener. Everyone comes from a different, unique environment, with individual problems and questions for which other participants may have already found solutions. This seminar is primarily aimed at people who support economic actors - i.e. manufacturers, importers, dealers and authorized representatives - with the introduction of the MDR. This group has already dealt with the regulation more intensively. Therefore, the discussion between the participants is particularly important.
What added value can the participants derive from your seminar series?
During the seminar, not only the personal knowledge of the seminar leader is imparted. Together we look for and discuss pragmatic solutions to regulatory challenges.
Participants can send you questions, ideas, suggestions or topics they would like to discuss in advance. Why are you making this specific offer?
The participants come from a wide variety of companies, deal with a wide variety of technologies, face a wide variety of challenges and have different levels of knowledge. Normally, such information is only obtained once the event has already started. At our seminar, the participants can communicate their needs and their focus in advance. This allows me to prepare differently as a seminar leader and adapt the main focus.
What makes you an expert on the EU-MDR?
I have worked in the approval and verification of medical devices and products for over 40 years. In doing so, I gained experience in the field of testing, audits of quality management systems and the certification of products and systems. Through my many years of work, including with the European Commission, I have gained insight into the way of thinking and the procedures of the legislative bodies in Europe. I believe that I can judge the requirements of the law quite well and thus assess the effects on economic actors.
What can participants look forward to in your seminar series?
You can count on an open and purposeful discussion of the actual
