Structured Requirements at a Glance
New - Version 1.0
Requirements, Traceability and Testing for Medical Device Development
Medioora combines requirements, traceability, design and testing in a single platform. Built for compliant medical device development with complete traceability from requirement to verification.
- IEC 62304, ISO 13485 & MDR ready • Audit-ready documentation • Complete traceability from requirement to test • Fully versioned change history
Built for Medical Device Development
Ready to Use
Features
Everything your team needs.
Medioora brings all essential features together in one intuitive interface.
End-to-End Traceability
Integrated Documentation
Integrated Reviews
AI for Faster Engineering
Onboarding
Teams Ready in 3 weeks
Complete onboarding package including setup, training, and go-live support.
Week 1
✓
Workspace Setup
Setting up the workspace and importing existing templates.
Week 2
↻
Onboarding admins and users
Roles, permissions, processes and hands-on training for all teams.
Week 3
→
Go-live, support and first requirements
Joint go-live, rapid support and the start of first requirements.
Frequently Asked Questions & Answers
Quick answers to the most important questions about Medioora.
Medioora was specifically developed for medical device companies that need to manage requirements, design, risks, and testing in a single platform. It is particularly well suited for teams working in accordance with IEC 62304, ISO 13485, or MDR requirements and requiring complete end-to-end traceability.
With our setup package, you’ll be up and running in three weeks: setup, onboarding and go-live with hands-on support.
Requirements management, traceability, task management, collaboration, version control, documentation, testing, and releases in one central platform.
Yes. Existing templates can be imported and saved as team standards in your workspace.
We guide admins and users hands-on through roles, permissions, workflows and daily use of the tool.
Security and traceability are at the core. Access, changes and approvals can be documented transparently.
Yes. We support you at launch, help prioritise initial requirements and assist with refining your processes.
No. The platform is designed for rapid adoption and is rolled out iteratively with your team.