Quality management is challenging in the medical field and even more so when you are 3D printing medical devices. Yet it is crucial to produce safe and effective devices, which is the main regulatory requirement. In this presentation I will talk about quality management and the additional risks associated with 3D printing.
January 2025, 12th edition, The Netherlands
A presentation by Erik Boelen, Quality consultant medical 3D printing at QasE3D.
Erik truly believes that every patient deserves a patient-specific implant, tuned to his/her anatomy. 3D printing can enable us to make these perfect, unique implants, provided we do it right. There still is a lot of work in safeguarding the quality of 3D printed implants.
On short term, we would need proper and clear regulatory requirements, guidance and standards to assure quality in 3D printing of medical devices, and in the long term, he is excited to see where xolography can take us!
About Erik Boelen
Dr. ir. Erik Boelen has over 15y experience in medical 3D printing. Erik currently has his own consultancy company (QasE3D) in medical 3D printing and Quality Management; mainly helping 3D printing companies towards ISO 13485 certification. Before, Erik was employed at Xilloc Medical B.V. for 9 years (April 2012 – June 2021) as Chief Operations Officer; Xilloc designed and manufactured some world’s first patient-specific and 3D printed medical devices. Previously, Erik held various positions at 3D printing pioneer Materialise NV; Marketing Manager (January 2011 – May 2012), Sales Manager Biomedical Asia-Pacific (February 2010 – January 2011), Product Specialist (June 2007 – February 2010) and Application Engineer (January 2007 – June 2007).
Qase3D helps companies with 3D printed medical devices to build and implement a lean and fully digital quality management system for ISO 13485.
Also, QasE3D supports hospitals in setting up a high quality Point-of-Care (PoC) 3D printing facility.
For more information, visit the website.
Erik Boelen is speaker at the 2023 edition of the 3D Medical Conference.