There’s an ongoing trend towards the personalisation of medical devices. Many of these custom-made implants are 3D printed. But how do you design and manufacture high quality devices? What QMS do you need for 3D printed medical devices? QasE3D can help! Qase3D can kickstart your ISO 13485 certification with the setup and implementation of an …
Years of experience
3D printed devices
Qase3D is founded by Erik Boelen, MSc, PhD in order to help medical 3D printing companies with their Marketing and Quality challenges and to connect surgeons to high quality devices. 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 …
3D printing or Additive Manufacturing allows for complex and organic designs, mimicking, matching and/or mirroring human anatomy. Furthermore, it allows the production of porous structures, enabling osseointegration. 3D printing facilitates mass customization; custom-made (or patient-matched) devices for every patient. But also standard medical devices can be 3D printed (with a lattice structure), for example spinal cages and acetabular cups.
Providing it is done right, definitely yes. But, same as with other manufacturing technologies (like CNC milling) you need good control of the whole workflow, not only the process of 3D printing, but also the design, raw material, post-processing, cleaning, sterilisation. That's were a Quality Management System comes in.
eQMS is a fully digital QMS system, dedicated for custom-made and/or 3D printed medical devices. So it's not a paper-based QMS, nor is it a collection of Word documents. eQMS is HTML-based, so it works in your browser.
No, eQMS is built on a popular system for team collaboration. As such it becomes a "living QMS", because people are working in the system and it is part of their daily routine. It will become the knowledge base (wiki) of your company. Contrarily, a dedicated QMS system is typically only used by the Quality Manager.