Panel Discussion

Formlabs x TÜV SÜD: Exploring Additive Manufacturing and Regulatory Requirements in the EU

Watch this panel discussion featuring guest speakers from TÜV SÜD, a notified body for medical devices, as they delve into the regulatory requirements for additive manufacturing of medical devices. Don't miss this opportunity to learn more about using 3D printing for medical device production.

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What you'll learn:

  • Are there differences in the requirements of the Medical Device Regulation (MDR) for 3D-printed implants compared to traditionally manufactured implants?

  • What is the difference between Custom Made and Patient Specific?

  • What steps need to be taken to obtain CE marking for 3D-printed medical devices under the MDR?

  • Does the printed device for my implant also need to undergo biocompatibility evaluation?

  • Must a material certified by the manufacturer be re-evaluated for its biocompatibility?

  • Material with intended purpose vs. material without intended purpose. Does it provide any facilitation?

  • How does the MDR affect the liability of manufacturers of 3D-printed medical devices? 3D printing manufacturers vs. end users

  • Are there guidelines specifically developed for 3D printing in the medical field?

  • Are there specific requirements for training personnel involved in the manufacturing or use of 3D-printed medical devices under the MDR?

  • How can one ensure that 3D-printed medical devices comply with the quality and safety standards of the MDR?

  • What role does traceability play in the manufacturing of 3D-printed medical devices under the MDR? Is an Excel sheet sufficient?


Featuring

Simon Schlagintweit

Medical Expert & Lead Auditor AM at TÜV SÜD

Andrea Pietsch

Director Global Strategic Business Development Orthopedics at TÜV SÜD

Shiden Yohannes

Medical Market Development Manager at Formlabs

Max

Co-founder and CEO at Formlabs

Webinar Chapters
9:09
 Adam explains the “Low Force” in Low Force Stereolithography (LFS)
13:31
 Deep dive into the light processing unit of the Form 3
25:19
 Choosing a material with the Formlabs workflow
31:00
 Faris shows how to use the Form 3
40:16
 Adam shows how to remove light touch supports

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