Why Medical Device Teams Choose Medioora
Medioora connects requirements, risks, design, and testing in one central platform and creates traceability at the click of a button.
Where Many MedTech Teams Lose Time Today
Scattered Documents
Requirements, risks, and tests are spread across Word, Excel, and multiple tools. Relationships get lost and changes become difficult to trace.
Standards and Evidence
IEC 62304, ISO 13485, ISO 14971, and MDR require traceable processes and complete evidence — often with significant manual effort.
Complex Tools
Many requirements tools are expensive, time-consuming to implement, and oversized for the needs of small and mid-sized MedTech companies.
Developed from Project Experience
Medioora was developed directly from the day-to-day engineering work of MEDtech Ingenieur GmbH. The system is used in real projects to document requirements, risks, architecture decisions, and test evidence in a structured and revision-ready way.
✓ Developed at MEDtech Ingenieur
✓ Used in real development projects
✓ Continuously improved based on practical project experience
Medioora vs. Traditional Requirements Tools
Typical Use Cases
From the first requirement to verification with complete traceability.
Centralized management instead of scattered documents and manual links.
Document evidence, changes, and relationships in a way that remains traceable at all times.
Structured development processes without complex enterprise systems.
Cloud or on-premise deployment for maximum control over development data.
Feature Overview
Requirements Structure
Structure URS, system, subsystem, software, and hardware requirements.
Versioning
Track changes, compare baselines, and preserve the complete history.
Traceability
Link requirements with risks, architecture, and tests.
Review Workflows
Reviews and approvals with clear roles and status tracking.
Documentation Export
Efficiently export evidence for technical documentation.
Roles and API
Role management plus optional API interfaces.