Medical 1

Medical

First Qualified Point-of-Care AM Production Site in a Hospital

Ukm
First Qualified Point-of-Care AM Production Site in a Hospital
UKM became the first hospital worldwide to successfully implement a qualified additive manufacturing production site under ISO/ASTM 52920. This pioneering achievement establishes a new benchmark for hospital-based AM production, demonstrating that in-house manufacturing of patient-specific models can be performed at a regulatory-compliant, high-quality level.
80% Cost Reduction in QMS Implementation
The implementation of a fully compliant QMS was completed in just four months, significantly reducing the time and financial investment required for qualification. By leveraging Qualified AM’s expertise, UKM was able to accelerate the adoption of AM-specific quality controls while achieving an 80% cost reduction compared to conventional medical device manufacturing setups.
Standardized Process Qualification for Patient-Specific AM Parts
UKM successfully established a validated process for manufacturing personalized aortic arch models, ensuring consistency in production quality and repeatability in the surgical setting. The integration of Digital Light Processing (DLP) technology with validated material handling, post-processing, and sterile packaging procedures ensures that every manufactured part meets the highest quality standards for medical applications.
Universitätsklinikum Münster (UKM)
Martin schulze
Ukm

Martin Schulze

Head of the Experimental Orthopaedics (Location ZMK) - Priv.-Doz. Dr. rer. medic. Dr. med. habil. Dipl.-Ing.(FH)
Qualified AM GmbH's value proposition is unparalleled. Their expertise swiftly prepared us for Point of Care Additive Manufacturing, ensuring full compliance with MDR requirements and seamless preparation for ISO 13485. Their exceptional service has set a new standard in the medical AM industry.

First Qualified Point-of-Care AM Production Site in a Hospital

The Qualified AM team performed a part process qualification at the Universitätsklinikum Münster (UKM).  At the hospital’s internal additive manufacturing production site, surgical tools and test parts are manufactured. UKM is globally the first hospital that has a qualified point-of-care (POC) production site to ensure patients receive the best care, as fast as possible. Qualified AM delivered qualification of the additive manufacturing production site with the patient-specific aortic arch replica as a focus point part. This model is used for tactile navigation within the operational environment and produced internally at UKM.

The Qualified AM team performed a part process qualification at the Universitätsklinikum Münster (UKM).  At the hospital’s internal additive manufacturing production site, surgical tools and test parts are manufactured. UKM is globally the first hospital that has a qualified point-of-care (POC) production site to ensure patients receive the best care, as fast as possible.

Qualified AM delivered qualification of the additive manufacturing production site with the patient-specific aortic arch replica as a focus point part. This model is used for tactile navigation within the operational environment and produced internally at UKM.

Standards
  • ISO/ASTM 52920:2023
  • DIN EN ISO 13485
  • MDR Annex I
Typical audit
areas and achievements
ISO/ASTM 52920 compliance
To satisfy the ISO/ASTM 52920 with the main goal to reduce process variables that impact the reproducibility and quality of the process output.
MDR requirements
UKM achieved full alignment with the MDR Annex I safety and performance requirements.
ISO 13485 readiness
By implementing an AM QMS compliant with ISO/ASTM 52920, UKM achieved readiness for full ISO 13485 compliance in its additive manufacturing operations.
QMS development
The entire quality management system was completed in only four months. By utilizing the Qualified AM QMS service, UKM was able to save 80% of the implementation cost.
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