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Prüfverfahren 3D-gedruckter Medizinprodukte

30. September 2021 · 14:00 – 18:00 Uhr

Ein Workshop für Mitarbeiter aus Orthopädie-technikunternehmen, Krankenhäusern, Arztpraxen und wissenschaftlichen Einrichtungen.

Dr. Cora Lüders-Theuerkauf Mobility goes Additive e.V. und Simon Schlagintweit TÜV Süd sprechen über:

  • Prüfverfahren
  • Testmethoden
  • Normung, Standardisierung
  • Zulassung (MDR, FDA)

Teilnahmegebühr: 49,- €
Für MGA-Mitglieder kostenlos

cora.lueders@mga-net.com
+49 (0)152 031 980 22

MGA Mobility | MGA Medical
Mobility goes Additive e.V.
Im Marienpark 22
12107 Berlin

 

Sonderbeilage Mobilität der Zukunft in der CAPITAL

Am 21. Oktober 2021 veröffentlicht der in|pact media Verlag eine Sonderbeilage „Mobilität der Zukunft – Technik, Trends, Innovationen“ in der Gesamtauflage der CAPITAL mit einer Reichweite von 860.000 Lesern/innen. Ein Thema der Ausgabe wird „3D-Druck – Innovative Materialien für den Mobilitätssektor“ sein:

Stefanie Brickwede wird sich dort als Expertin imForum der Akteure inhaltlich beteiligen.

Falls Interesse besteht, in diesem Zusammenhang Anzeigen zu schalten, einen Sponsoren-Gastbeitrag zu verfassen oder ein Experteninterview zu geben, kontaktieren Sie gerne direkt Michael Stoephasius.

MGA Mitglieder erhalten bis zum 3. September 20% Rabatt.

Women in AM summit impressions

3D industrial – our unified voice for industrial 3D printing in Germany

The innovation and technology leaders are located in Germany. At the same time, massive, strategic and very effective investments in industrial 3D printing are being made worldwide, by countries such as the USA and China. Germany and its companies are therefore in danger of being left behind in this competition.

Therefore, we decided to found 3D industrial, an initiative of German “thought leaders” in the field of industrial 3D printing. As a loose association of companies that deal with the use of additive manufacturing in industrial production, covering the entire value chain. All participants are united by the focus on the industrial use of 3D printing. The aim is not to deal with standardization or technology, nor to establish a new platform for networking between companies.

Rather, the aim is to jointly address decision-makers in politics, government, authorities and civil society. The goal is to inspire them to create the right framework conditions for the successful integration of additive manufacturing into industrial production.

Our main claims:

  1. development and implementation of a “National Additive Manufacturing Strategy”
  2. inclusion of industrial 3D printing in education and training
  3. more dynamic promotion of research and development
  4. supporting investments in sustainable supply chains

To achieve this, the initiative needs YOUR SUPPORT – especially in this exciting election year and after the formation of a new federal government.

To get a first impression, please find a current position paper of 3D industrial below.



If you are interested in participating, contact us for a more detailed presentation. Further information is also available on the website www.3dindustrial.org.



We look forward to lively participation, because only together can we ensure that future innovations in the field of additive manufacturing take place in Germany and Europe.

MGA Medical Working Group Approval Result: MDR Decision Tree

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

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.

MGA 3D printing KidsCamp – An After Report

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

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

Look who’s visiting us at our offices in the Marienpark

In March Franziska Giffey, SPD Berlin top candidate for the office of Governing Mayor in Berlin and back then Minister for Family Affairs, Senior Citizens, Women and Youth visited our IAM Hub. As part of her “matter of the heart” tour, we were able to communicate our heartfelt topic of additive manufacturing with commitment.

In May we once again welcomed esteemed guests, this time Michael Müller (Reigning Mayor of Berlin) & Ramona Pop (Berlin Senator for Economic Affairs, Energy and Operations) were very interested to learn about the possibilities of 3D printing.

The district mayor of Tempelhof-Schöneberg (where our office is located), Angelika Schöttler, also came to the Marienpark and we are happy to always push the topic of AM.

Having all these guests at our offices shows that 3D printing is a technology that no one can ignore and our voices are being heard.

Together WeBoostAM!

Book recommendation: (German) IT Law – law, business and technology of the digital transformation

The handbook not only provides solid basic legal knowledge of German IT law, but also the technical and economic understanding of current key technologies. It is suitable as a working aid for in-house counsel and corporate lawyers who want to inform themselves about the current “hot spots” of digital transformation in the industry with a manageable expenditure of time.

Advantages of the work:

  • Practice-oriented presentation of current developments and their economic and legal significance
  • Easy-to-understand presentation of technical backgrounds
  • Practical tips, examples and formulation suggestions for all sub-areas of IT law

About the author https://www.linkedin.com/in/andreasleupold/

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.

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