Connecting

Connecting surgeons to high quality 3D printed medical devices

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Quality

Implementing an ISO 13485 Quality Management System

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3D Lab & Design

Dedicated design for 3D printing of medical devices

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Quality in 3D printed medical devices

There’s an ongoing trend towards the personalisation of medical devices. Many of these custom-made or patient-matched implants are 3D printed. But how do you ensure the safety and efficacy of your 3D printed devices? How do you ensure consistent quality? For this you need a Quality Management System (QMS)! Qase3D can kickstart your ISO 13485 …

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About QasE3D

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 …

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  • Why use 3D printing for medical devices?

    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.

  • Is 3D printing suitable for medical devices? Is it safe?

    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.

  • What is eQMS

    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.

  • Is eQMS a dedicated QMS software system?

    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.