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.
THE CHALLENGE
Technology is ready. Compliance isn’t.
As a hospital-based engineer or physician, your priority is the patient. When you produce patient-specific medical devices in-house, the European Union Medical Device Regulation (EU MDR) 2017/745 sets clear requirements for how they are made, documented and monitored.
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Non-compliance can compromise patient safety and expose your lab to legal liability, failed audits, and operational disruption.
Building a compliant quality management system (QMS) and the evidence for your medical devices from scratch is resource-intensive. It 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.
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OUR SOLUTION
The Infrastructure Behind Compliant Point-of-Care Production
POC APP brings together the digital systems, evidence, documentation and expertise needed to establish and operate point-of-care medical device production. We set it up with your team. You run it, with us beside you.
01
Digital infrastructure
POC APP Online
An ISO 13485-aligned digital platform combining electronic quality management system, manufacturing execution system with validated production workflows and traceability for your medical devices.
02
Device and Regulatory infrastructure
Documentation for every device
Technical documentation, including risk management, biocompatibility, verification, validation and clinical evaluation, structured around your devices, processes and regulatory responsibilities.
03
Implementation expertise
Expert support
Lab setup, workflow integration, staff training and ongoing quality and regulatory support from people who have led patient-specific device production in hospitals.
WHAT YOU CAN PRODUCE
Build Your Production Capability Step by Step
From anatomical models to advanced patient-specific medical devices, POC APP provides the infrastructure to support your lab as its clinical capabilities grow.
Getting started
Anatomical models
Establish the foundations for documented, repeatable point-of-care production.
Going clinical
Surgical guides, Splints and Orthoses
Extend your production system to patient-specific devices used in routine clinical care.
Advanced manufacturing
Patient-specific implants
Extend your framework to the additional regulatory, validation, biocompatibility and clinical requirements associated with advanced patient-specific devices.
HOW IT WORKS
From Your Current Setup to Compliant Medical Device Production
01
Gap analysis
We assess your lab, devices, workflows and equipment to identify what your target production needs.
02
Integration
We implement the quality, documentation, digital and production framework around your team and infrastructure.
03
Go live
Your team runs a documented, traceable production workflow, with ongoing support from POC APP.
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Real results. Real hospitals.
POC APP has supported European hospitals in establishing point-of-care production of more than 150 patient-specific 3D-printed implants.
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See how hospitals have moved from 3D printing capability to routine, clinically implemented production.
University Hospital Basel, Switzerland
First in-house manufacturing of a patient-specific cranial implant, now expanded to facial implants. Enabled by POC APP.
Salzburg University Hospital, Austria
First in-house production and implantation of a patient-specific cranial implant in Austria.
Enabled by POC APP.
