Qase3D was founded from a simple belief: every patient deserves personalised patient care.
For that vision to become reality, 3D surgical planning, anatomical models, surgical guides and patient-specific implants must be done the right way — with consistent quality, validated processes and full compliance with medical regulations.
That’s why Erik Boelen, MSc, PhD, founded Qase3D: to help medical 3D printing teams bridge the gap from clinical innovation to lean quality management and regulatory confidence.
Erik is a biomedical engineer from Eindhoven University of Technology and has a PhD in biomaterials (for spinal surgery) from Maastricht University, The Netherlands.
In his professional career he worked for >15 years with 3D printing and (custom-made) medical devices, for well known companies as Materialise and Xilloc.
Erik has ample experience in Sales and Marketing, Quality Management and Operations Management. He is well aware of the challenges that companies face to market 3D printed devices (compliant with the MDR) and to control the quality of 3D printed devices.
Having struggled with a paper-based Quality Management System (QMS), Erik built a fully digital Quality Management system based on ISO 13485, that has been certified to ISO 13485: 2016 for custom-made devices. This eQMS can easily be adapted to the scope and activities of medical device companies.
Also setting up a 3D Design and 3D Print lab is part of Erik’s expertise, and he can help your company in:
- selecting the right machines and softwares for your 3D lab.
- designing devices specifically for 3D printing, taking the (im)possibilities of the various 3D printing technologies into account (e.g. design a porous lattice structure for a spinal cage or orthopaedic implant for osseointegration).
