---
title: "Qase3D introduces MDR system form hospital 3D labs"
url: https://www.voxelmatters.com/qase3d-introduces-mdr-system-form-hospital-3d-labs/
date: 2025-12-13
modified: 2025-12-13
lang: en
author: "Edward Wakefield"
description: "Point-of-Care (PoC) manufacturing facilities and other producers of custom-made medical devices must comply with the European Medical Device Regulation (MDR). One of the core requirements under the MDR is the..."
categories:
  - "Medical AM"
  - "Standards"
tags:
  - "insights"
image: https://www.voxelmatters.com/wp-content/uploads/2025/12/mdr_poc_header-640x293.jpg
word_count: 440
---

# Qase3D introduces MDR system form hospital 3D labs

Point-of-Care (PoC) manufacturing facilities and other producers of custom-made medical devices must comply with the European Medical Device Regulation (MDR). One of the core requirements under the MDR is the implementation of a Quality Management System (QMS). Although [ISO 13485 is the globally recognized standard](https://www.voxelmatters.com/oechslerhealth-qualifies-iso-13485-additive-manufacturing-line-for-medical-devices/) for medical device QMS, it is often too extensive for small manufacturers such as hospital-based 3D labs - while still not covering every MDR requirement. As a result, even fully ISO 13485-certified organizations must perform additional MDR-specific activities. Recognizing this gap, [Qase3D, a 3D printed medical device company](https://www.voxelmatters.directory/company/qase3d/), and Waveland European Lawyers have partnered to introduce a streamlined MDR Management System tailored specifically to hospital 3D labs producing custom-made anatomical models, surgical guides, and patient-specific implants.

The solution builds upon Waveland’s proven online platform - widely used by podiatrists in the Netherlands, who, like PoC labs, are classified as small medical device manufacturers. The platform translates complex MDR requirements into clear, actionable policies written in plain language. Users work through 18 structured chapters, completing checkboxes, forms, and tables related to their organization and products. Once the platform reaches 100%, the user knows they meet the MDR requirements for custom-made devices.

Unlike [traditional QMS implementations](https://www.voxelmatters.com/kam-invests-in-security-digital-erp-mes-qms/), the Waveland platform focuses solely on what the MDR legally requires - nothing more and nothing less. The platform can function as a stand-alone MDR Management System for small manufacturers or can be integrated into an ISO 13485-based QMS for larger facilities. Waveland ensures continuous compliance by maintaining the content in line with evolving legislation.

As part of the collaboration, Qase3D provides onboarding, initial implementation, and an annual audit. With extensive experience in hospital 3D printing operations, Qase3D ensures PoC labs understand both the regulatory context and the practical reality of producing patient-specific devices.

"While supporting several PoC labs in building their ISO 13485 QMS, I received more questions about the MDR than about the standard itself. Because the goal isn’t to build a QMS, the goal is to achieve MDR compliance. I discovered that to truly understand the MDR, we need European legal expertise. That search led me to Waveland. Their MDR portal was an eye-opener; I never expected MDR compliance could be achieved so practically," said Erik Boelen, Founder of Qase3D.

"It’s in my DNA to make complex things simple. With Waveland, we translated the MDR into clear, understandable language and practical actions. Our MDR Management System is recommended by the National Podiatry Association in the Netherlands. Together with Qase3D, we adapted the system so European hospitals can now benefit from the same simplicity when producing custom-made devices at the Point-of-Care," said Benedikt Marijnen, Founder of Waveland European Lawyers.