01
Gap analysis
We analyze your current setup and define the right compliance framework.
02
Integration
We integrate the POC APP Online solution into your lab and train your team.
03
Go live
Your lab is ready to produce MDR-compliant devices, on a timeline that depends on where you start.
REAL-WORLD SCENARIOS
See how hospitals move from printing to production
GETTING STARTED
From workshop tools to a first patient case.
The lab prints tools for the hospital, until a surgeon asks for an anatomical model. Can they prove it’s ready for patient care? Nothing has ever been documented. POC APP turns the lab’s routines into a documented, controlled workflow before the first patient case.
GOING CLINICAL
When the audit asks for the evidence.
The lab prints models and guides every week. Then an auditor asks for the file behind last month’s mandibular guide, and the print logs can’t answer. POC APP builds the documentation, risk files and traceability for every device, before the audit asks.
ADVANCED MANUFACTURING
Ready for implants, but the file isn't.
The lab wants to make implants, but implants need far deeper evidence than its existing file holds. POC APP extends the same framework with the biocompatibility, testing and clinical evidence implants require, so the lab doesn’t have to start over.
FAQ
Frequently asked questions
Material safety is one piece of it, not the whole picture. You also need evidence that the specific device, printed on your specific machine with your specific process, meets the safety and performance requirements for its intended use. A material data sheet alone can't show that.
Yes. MDR Article 5(5) exempts in-house production from most MDR provisions, including CE marking, but only if all its conditions are met: a quality management system, documented evidence and a justified patient need. The Annex I safety and performance requirements always apply. It’s an exemption you earn with evidence, not a blanket pass.
Not on its own. A QMS, even one certified to ISO 13485, provides the framework for consistent, controlled processes. It doesn’t show that a specific device, production process and intended use meet the regulatory requirements. Device-specific documentation, risk management and evidence are still needed.
Often, yes. What counts is the intended purpose. A surgical guide used during an operation is a medical device. An anatomical model used to plan or decide on an individual patient’s treatment usually is too. The intended purpose also determines which requirements apply.
The hospital. As the manufacturer of its in-house devices, the hospital retains responsibility for meeting the applicable requirements. POC APP provides the infrastructure, evidence documentation and support for a controlled, traceable production system.
