EU MDR compliance infrastructure for Point-of-Care 3D printed medical devices.
TURNKEY PRODUCTION PROCESSES
Validated manufacturing workflows for 3D-printed, patient-specific anatomical models, surgical guides, orthoses, and high-risk Class IIb & III implants.
EU MDR COMPLIANT FRAMEWORK
An EU MDR-compliant QMS and evidence-based product documentation according to MDR Annex I.
EXPERT PARTNERSHIP
Work alongside experts in hospital-based 3D printing to establish a sustainable process of continuous improvement.
Our compliance infrastructure covers the full range of Point-of-Care devices:
Implants
Surgical Guides
Anatomical Models
Wrist Orthoses
What's included?
POC APP Online: Digital Systems & Regulatory Documentation
Everything your print lab needs to go from idea to audit-ready device.
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ISO 13485 aligned electronic QMS
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Manufacturing Execution System (MES) for end-to-end traceability
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Production process qualification and validation
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Equipment and software qualification
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Risk management and biocompatibility evaluation
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Technical documentation and clinical evaluation
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Risk-based evidence documentation
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Post-market surveillance and lifecycle management
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Audit-ready documentation
Training and Implementation
Hands-on support for your hospital team.
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Lab setup and workflow implementation
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Staff training for engineers, clinicians and quality managers
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Ongoing regulatory and quality support
