Medical 3D printing has come a long way, but the regulations are still catching up. As personalized medical devices move into hospitals, how can labs innovate while staying compliant? Erik Boelen, founder of medical 3D-printing compliance consultancy Qase3D and former Chief Operations Officer of Xilloc Medical, has a solution. Boelen built an ISO 13485 quality system from scratch at Xilloc, which produced the world’s first complete 3D-printed titanium mandible in 2011. Today, he helps newer medical 3D-printing companies and hospital labs navigate the European Medical Device Regulation (MDR), emphasizing that MDR compliance does not necessarily require a full ISO 13485 system. Through Qase3D, Boelen has developed an MDR Management System with Waveland European Lawyers, an online portal that breaks down regulatory requirements into practical steps for custom-made device manufacturers. As hospitals increasingly become manufacturers themselves, Boelen integrates compliance systems that protect patients without creating unnecessary bureaucracy.
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This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.
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About Our Guest:
Dr. ir. Erik Boelen runs his consultancy, “Qase3D” (pronounced Case-three-dee) specializing in medical 3D printing and Quality Management. He assists 3D printing companies and hospital labs with ISO 13485 certification and MDR compliance. Erik served as Chief Operations Officer at Xilloc Medical B.V. for nine years (April 2012 – June 2021), where the company designed and manufactured some of the world’s first patient-specific, 3D printed medical devices. Before that, he held various roles 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).
Key Topics
- Twenty years of medical 3D printing and the evolution of regulation
- Medical 3D printing before the MDR and the regulatory gaps of the MDD era
- Understanding the MDR, CE marking, custom-made devices, and ISO 13485
- Xilloc and the world’s first complete 3D-printed titanium mandible
- Patient safety and the shift from self-regulation to formal standards
- The 2017 MDR and its impact on custom-made medical devices
- Building an ISO 13485 quality management system from scratch
- How Qase3D helps medical 3D-printing companies and hospital labs navigate compliance
- Designing a quality management system that engineers will actually use
- Why smaller labs may not need the full weight of ISO 13485
- Where the MDR and ISO 13485 overlap, and where their requirements differ
- Lean compliance, documentation, and reducing the cost of regulatory management
- Implants, Class III devices, and when more rigorous quality systems are needed
- GDPR, lawyers, and protecting patient data in personalized medical devices
- The rise of hospital 3D labs and the future of hospitals as medical device manufacturers
Timestamps:
00:00:00 – Welcome To The Regulatory Reality
00:03:10 – MDR, CE Mark, And ISO 13485
00:06:30 – Making Implants Before Clear Rules
00:08:33 – What Custom Made Really Means
00:10:20 – From Engineer To Quality Builder
00:12:12 – A Lean QMS People Actually Use
00:17:33 – The MDR Portal And Lawyer Support
00:26:45 – Scaling Compliance Without Bureaucracy
00:30:40 – The Future Of Hospital 3D Labs
00:41:05 – How To Contact Erik
00:43:15 – Disclaimer
Resources
🔗 Contact Erik Boelen
- Erik Boelen on LinkedIn
- Qase3D on LinkedIn
- Qase3D
- About Qase3D & Erik Boelen
- Qase3D Quality BluePrint 5D Method
🔗 MDR, ISO 13485 & Point-of-Care Compliance
- EU Medical Device Regulation (MDR)
- Qase3D MDR Management System
- MDR Custom-Made Devices
- Waveland European Lawyers MDR Point-of-Care Platform
- Qase3D Point-of-Care Compliance
- Qase3D Custom-Made Devices and the MDR
- ISO 13485 Medical Devices Quality Management Systems
🔗 Xilloc & Medical 3D Printing
- Xilloc
- World’s 1st complete 3D-printed titanium mandible in 2011
- Materialise Mimics
- Materialise Medical
- 3D Printing Industry: Qase3D and Waveland Introduce MDR Management System
- 3DHEALS: Updates on 3D Printed Medical Devices
🔗 Learn More About Medical 3D Printing from 3DHEALS!
- 3DHEALS
- Interview with Erik Boelen: Quality Management for Point-of-Care 3D Printing
- 3D Printing at Point-of-CARE with Quality
- Point of Care Additive Manufacturing
- 3D Printing in Hospitals: The Road to Reimbursement
- A World of Regulation: Updates on 3D Printed Medical Devices
- 3D Printing in Hospitals: A Beginner’s Guide
- Strategic Issues of 3D Printing in Hospitals
- 3DHEALS Policy Guide: Six Policy Areas Impacting Healthcare 3D Printing
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