MGA Medical Working Group Approval Result: MDR Decision Tree

Posted on August 11, 2021August 11, 2021 by Ingo Schepers

Anyone who has ever dealt with medical approval procedures knows the difficulties and mountains of questions and approval paths one is confronted with in this regard.

But no matter what you do, there is one thing you can’t avoid:

The Medical Device Regulation came into force on May 25, 2017, and is now finally applicable as of May 26, 2021. It comprises of 10 chapters, 123 articles and 17 Annexes, on more than 175 pages.

It is used for the risk classification of medical products, whereby the 22 classification rules from Annex VIII in particular must be observed. The MDR is formulated in comprehensive legal jargon and is difficult for non-specialists to understand and apply.

To break down this extensive construct, the experts from our Approval working group, lead by Simon Schlagintwelt (TÜV Süd Product Service GmbH) and Dr. Cora Lüders-Theuerkauf (Mobility goes Additive e.V.) have jointly developed a simplified procedure. The decision tree, which they have designed, is arranged in a clear structure, which guarantees an easy and quick orientation.

Here, the 22 classification rules are simplified and structured in a way that by answering simple “Yes”/” No”-Question one can find the associated risk to one’s device.

The user is being navigated through the questions automatically and arrives at a result by simply following the path.

It is available to MGA members free of charge in the internal members’ area of the MGA website as a PDF file. External interested parties can also purchase it, for more information please contact us directly at info@mga-net.com.

MGA Medical goes Additive: Medical Potential Studies

Posted on August 11, 2021August 11, 2021 by Ingo Schepers

Additive manufacturing is being used widely in the medical sector. In particular, the various departments of hospitals often access its extensive applications. The major advantages here are the individual fit, freedom of design, speed of production, and cost savings. But how great is the actual potential of medicine and medical technology in terms of using additive manufacturing in Berlin? To answer this question, we at Medical goes Additive conducted a potential study: For this purpose, research was conducted and expert discussions were held over several months to determine the specific needs in the medical sector and to get to know the most important players of said sector in Berlin. It became clear that most representatives of the industry would like to see more networking within the Berlin 3D printing community and that there is a great need for cooperation and alliances. The Industrial Additive Manufacturing (IAM) Hub, which opened in October 2020 on the Marienpark site in the south of Berlin, provides a suitable basis for a central contact point for establishing Additive Manufacturing in the medical sector in the capital: In Berlin-Mariendorf, a dedicated micro-ecosystem with campus character is being created. The topics of co-working, training, research and development, as well as AM events, find a new home here. Check out our medical potential study and find out which areas of the medical industry are particularly promising for the use of Additive Manufacturing.

Abschlussbericht Potentialstudie im Medizinsektor | 742.36 KB

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MGA 3D printing KidsCamp – An After Report

Posted on August 11, 2021August 11, 2021 by Ingo Schepers

Our experience is that most schools already have 3D printers, but far too few people who know how to use them. We wanted to change that – and the idea for our 3d printing KidsCamp was born! We want to share our enthusiasm for 3D printing with kids, introduce them to the technology and give them the opportunity to design and print parts on the computer themselves.

So this summer for the first time ever and supported by Ultimaker and Autodesk we welcomed 17 Kids in two consecutive weeks at our IAM Hub in Berlin for the MGA 3D printing KidsCamp!

In the past weeks, we have been teaching the next generation all about our amazing technology. The kids have spent time with us at our MGA site, learning about Additive Manufacturing not only in theory, but putting their visions into practice.

The two groups, each staying for one week, have taken their first steps into the world of Additive Manufacturing and implemented their knew knowledge of CAD programs by printing their own 3D objects. Our joint lunch breaks were used to exchange ideas, followed by many fun activities.

Now that our time is over, we are very happy about the outcome and would like to thank Ultimaker and Autodesk for helping us bring this project into reality.

We are already excited for next year and are hoping to host more excited kids in 2022!

Pressemitteilung des Bezirksamtes Tempelhof-Schöneberg

Posted on August 11, 2021August 11, 2021 by Ingo Schepers

Die Liste der interessierten Politiker_innen an mag (mobilitiy goes additive) ist mittlerweile lang. Dieses Mal war es Bezirksbürgermeisterin Angelika Schöttler, die sich gemeinsam auf den Weg zu Stefanie Brickwede (Managing Director mag e.V.) in den Marienpark gemacht haben.

Für Angelika Schöttler und die Wirtschaftsförderung war es allerdings nicht der erste Besuch an diesem spannenden Ort. Dieses Mal sollte es aber um Ideen zur Zusammenarbeit gehen.

Was macht eigentlich der mag e.V.? Keine Frage, 3D-Druck ist derzeit in aller Munde und wird oft als eine der Schlüsseltechnologien der Industrie 4.0 angesehen. Aber die Strategie „Lasst uns einen Drucker kaufen und anfangen zu produzieren” erweist sich meist nicht als die beste, so heißt es auf der Webseite.

Wichtigste Ziele des Netzwerks sind die gemeinsame Entwicklung innovativer Produkte sowie der Know-How und Informationstransfer auf dem Gebiet. Das 3D-Netzwerk, das mittlerweile auf über 120 Mitgliedern besteht ist international aufgestellt.

Immer wieder ist es verblüffend zu sehen, welche Produkte sich mittels 3D-Druck herstellen lassen. Anwendungsmöglichkeiten sind quasi unbegrenzt. Ob es Implantate, Bauteile, Orthesen, menschliche Organe zu Übungszwecken für Mediziner_innen sind. Mittlerweile ist fast alles möglich.

‚Ich bin davon überzeugt, dass diese wichtige Zukunftstechnologie mit ihren unzähligen Anwendungsmöglichkeiten in Berlin den idealen Standort gefunden hat. Hier konzentrieren sich Forschung, Wissenschaft und Fachkräfte auf kleinem Raum. Der mag e.V. mit seinem großen Netzwerk entfaltet eine internationale Strahlkraft. Gerne sage ich meine Unterstützung zu, dieses Netzwerk auch in meinem Bezirk mit den im Umfeld befindlichen Akteur_innen zusammenzubringen‘, so Angelika Schöttler.

Dieses spannende Thema könnte auch für Kinder und Jugendliche sehr spannend sein, davon war Stefanie Brickwede überzeugt als sie die Idee hatte, in den letzten beiden Wochen der Sommerferien ein 3D-Druckcamp für Kinder von 11-15 Jahren zu organisieren. Das Interesse war umwerfend. Manches Kind wollte sogar ein zweites Mal mit von der Partie sein. Innerhalb

kürzester Zeit waren sie in der Lage Einkaufschips zu drucken. Ein tolles Erfolgserlebnis ist das für diejenigen, die vorher noch nie Berührung mit dem Thema hatten.

Kontakt:

Wirtschaftsförderung
Martina Marijnissen
Email: Martina.Marijnissen@ba-ts.berlin.de
Telefon: (030) 90277 – 4242

Day: August 11, 2021

MGA Medical Working Group Approval Result: MDR Decision Tree

MGA Medical goes Additive: Medical Potential Studies

MGA 3D printing KidsCamp – An After Report

Pressemitteilung des Bezirksamtes Tempelhof-Schöneberg

© MGA Mobility | MGA Medical - Mobility goes Additive e.V.

© MGA Mobility | MGA Medical - Mobility goes Additive e.V.

16.04.2024

Kick-Off Focus Group Dental

On April 16, 2024 the time has finally come: MGA Medical is kicking off a new Focus Group for the Working Group Use Cases.