Point-of-Care

MDR management system for compliance

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Medical Device company

ISO 13485 Quality Management System

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3D Printing company

Light ISO 13485 Quality Management System

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About QasE3D

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 …

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Safety and performance

All medical devices, including personalized/custom-made (patient-matched) devices, devices made under the healthcare institution exemption (point-of-care manufacturing) and 3D printed medical devices have to adhere to the applicable parts of Annex I of the MDR. This IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) guidance document might help to make sense of the Essential Principles of Safetyand Performance:

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3D printing at Point-of-Care

3D technology has found it’s way to the hospital and is significantly improving patient care. In the article below I highlight the opportunities and identify the risks of 3D printing in a hospital setting. It talks about regulatory and quality management aspects and links to helpful guidance documents.

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Procedures and form templates

Struggling with a certain Procedure (SOP) or Form templates in your ISO 13485-based QMS? Wouldn’t it be nice to get that documented procedure from a certified QMS that has stood the test of several Notified Body audits (and multiple continuous improvement iterations)? Via the form below you can request to receive one or more stand-alone …

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  • What is an MDR Management System, who needs it and why?

    The MDR Management System is designed for hospitals, 3D labs and medical device manufacturers that produce custom-made medical devices.
    These organisations must adhere to the European Medical Device Regulation (MDR). Our system makes compliance practical and straightforward; covering all essential QMS elements required by law, without the complexity of a full ISO 13485 system.

  • How is the MDR Management system different from the ISO 13485 quality system?

    The MDR Management System focuses on the (minimum) regulatory requirements of the MDR — practical, lean, and tailored for Point-of-Care 3D printing. The ISO 13485 quality system is a comprehensive QMS for medical device manufacturers, covering all the requirements of this quality standard.

  • Can we start without an in-house quality manager or QA team?

    Yes, with the MDR Management System you can. The system includes ready-to-use documentation, templates and clear guidance to work independently in full MDR compliance. Qase3D will support with its setup, training and yearly audits.
    For the ISO 13485 quality system, a responsible Quality Manager is strongly advised.

  • 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.

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