EU MDR COMPLIANCE INFRASTRUCTURE FOR HOSPITAL 3D PRINT LABS
Your print lab.
Fully compliant.
From the start.
Produce 3D-printed patient-specific anatomical models, surgical guides,
orthoses and implants in-house
SAFE. LEGAL. AUDIT-READY.
REGULATORY
CONFIDENCE
Produce 3D-printed medical devices under a validated, audit-ready EU MDR framework.
OPERATIONAL INDEPENDENCE
Reduce reliance on external manufacturers by producing compliantly in-house.
CLINICAL
IMPACT
Faster access to patient-specific devices - legally produced and fully documented.
Technology is ready. Compliance isn't.
As a hospital-based engineer or physician, your priority is the patient. However, the European Union Medical Device Regulation (EU MDR) 2017/745 introduces hurdles.
Non-compliance exposes your print lab to legal risks, failed audits, and operational disruption.
Building a compliant Quality Management System (QMS) as well as evidence for your medical devices from scratch is resource-intensive and requires specialized quality, technical, regulatory and clinical expertise that most hospitals lack.
POC APP provides the compliance infrastructure hospitals need to produce these devices safely and legally.
DIGITAL INFRASTRUCTURE:
POC APP ONLINE
Our customized digital framework acts as your lab's nervous system.
ISO 13485 aligned e-QMS
Managing your documentation, training, and standard operating procedures (SOPs).
Integrated MES
A Manufacturing Execution System to manage cases, materials, equipment, and end-to-end traceability - from initial design to final validation by the surgeon.
Regulatory Monitoring
We monitor your quality management and handle Non-Conformance Incidents (NCIs), providing immediate support and corrective actions.
REAL RESULTS. REAL HOSPITALS.
Supporting European hospitals in first-of-their-kind Point-of-Care 3D printing implementations.
POC APP's compliance infrastructure has supported the production of over 150 Point-of-Care 3D-printed implants across multiple European hospitals.
University Hospital Basel, Switzerland
First in-house manufacturing of a patient-specific cranial implant. Expanded in 2025 to include facial implants. Enabled by POC APP.
Salzburg University Hospital, Austria
First in-house production and implantation of a patient-specific cranial implant in Austria using Point-of-Care 3D printing. Enabled by POC APP.