Platomics announces new collaborations Read the Press Releases
PlatoX® Core
Build and maintain structured IVDR device documentation through guided workflows and connected regulatory data.
PlatoX® Core provides the foundation for creating, managing, and maintaining IVDR device documentation. Laboratories work through guided workflows covering device setup, Intended Purpose, workflow and component management, use environment, and user information.
Information is captured in a structured device record and reused across connected documentation. Standardized outputs can then be generated from the underlying data, reducing repetitive entry and helping laboratories maintain consistent documentation as devices evolve throughout their lifecycle.
PlatoX® Risk Management
Structure IVDR risk management by connecting hazards, risks, controls, and evidence in one traceable workflow.
Configurable risk matrices allow laboratories to reflect their own procedures, while reusable risks, controls, and evidence can be applied across their test portfolio where appropriate. Connected references help keep documentation aligned when shared information changes, creating a more consistent and traceable approach to risk management.
PlatoX® Performance Evaluation
Accelerate IVDR performance evaluation with AI-assisted evidence gathering, guided workflows, and automated documentation.
PlatoX® Performance Evaluation helps laboratories manage the evidence required for scientific validity, analytical performance, and clinical performance.
AI-assisted literature search supports evidence gathering, here’s what AI can and cannot do in IVDR documentation, and where your team stays in control, while guided plans, reports, templates, and automated documentation structure the evaluation process. Instead of searching, compiling, and formatting evidence manually across separate tools, laboratories can manage the process through a connected workflow. Performance Evaluation can be integrated with existing PlatoX® IVDR documentation or used independently as a standalone product.
Our commitment to quality
and data security
ISO 13485-certified quality management system since 2018
Services are housed in an ISO 27001-certified data center in Vienna
Get in touch
Platomics GmbH
An den Kohlenrutschen 10/3/7
1020 Vienna
AUSTRIA