From vision to compliant medical devices - in three steps
01
We analyze your current setup and define the right compliance framework.
02
We integrate the
POC APP Online solution into your lab and train your team.
03
Your lab is ready to produce MDR-compliant medical devices legally, on a timeline scoped to your starting point.
Where is your print lab today?
Getting Started
A hospital's 3D printing lab starts with practical tools - cable organizers, tool clamps, a hands-free door opener. Then a surgeon, impressed by the work, asks if the same printer could produce anatomical models for an upcoming case.
The team says yes, until someone asks how they'd prove it's ready for patient-facing work, and realizes nothing has ever needed to be documented before.
POC APP is built for exactly this moment: we help teams turn the process discipline they already have into the documented foundation EU MDR compliance requires, before the first patient-facing case forces the question.
Going Clinical
Two years on, the same lab is printing anatomical models and surgical guides routinely, and surgeons trust the results completely - cases have gone smoothly, nobody has ever second-guessed the workflow. Then a new quality manager, prepping for a routine audit, asks for the file behind last month's mandibular reconstruction guide: what confirmed it met its intended use, who signed off on the risk assessment. The team pulls up scan files and print logs — nothing that actually answers the question. The printing was never the problem. The evidence trail was.
POC APP builds that evidence — the device-specific technical file, risk documentation, and clinical evaluation — for every model and guide, before an audit ever asks.
Advanced Manufacturing
Three years in, with a compliant QMS and documentation POC APP helped build for their models and guides, the lab decides it's ready for the natural next step: implants.
They assume the existing framework already covers it. But when they bring the plan to their hospital's compliance team for sign-off, the answer is no: implants require a depth of device-specific evidence - beyond anything models and guides ever needed - that isn't part of the existing file. They're not unprepared because of skill, or even because of documentation in general. Implants simply demand more than what came before.
POC APP extends that same framework rather than starting over—building the additional evidence implants require —so the equipment and experience the lab has already invested in can be used for what it was bought for.
Frequently asked questions
