FAQ
Frequently Asked Questions
Everything you want to know about Medioora. Didn’t find what you were looking for? Contact us directly.
🎯 Product & Features
Medioora is a requirements engineering platform for the medical device industry. Requirements, traceability, documentation, design, and verification are managed centrally and linked together in a fully traceable manner.
Medioora was specifically developed for medical device manufacturers, MedTech startups, engineering service providers, and regulated development projects. It is particularly valuable for teams working according to IEC 62304, ISO 13485, or MDR requirements.
Key features include requirements management, traceability, document generation, versioning with diffs, review workflows, PDF and RTF export, dashboards, user roles, notifications, and AI-powered assistance.
Yes. Requirements can be linked to risks, architecture artifacts, design decisions, verifications, and tests. This ensures that relationships remain fully traceable and auditable at all times.
Yes. Existing requirements, documents, and templates can be imported and adapted to your company's individual development processes.
Documents and evidence can currently be exported as PDF and RTF files, making it easy to share content with customers, auditors, or notified bodies.
Medioora was specifically designed for regulated development processes and helps teams implement IEC 62304, ISO 13485, and MDR requirements through structured documentation and complete traceability.
☁️ Cloud, Self-Hosted & Enterprise
With the Cloud edition, Medioora is hosted, maintained, and secured by us. With the Self-Hosted edition, Medioora runs on your own infrastructure, giving you full control over operations, data, and security policies.
The Cloud edition is ideal for teams that want to get started quickly. Self-Hosted is best suited for organizations with specific security, privacy, or compliance requirements. Enterprise additionally includes consulting, training, and tailored project support.
Yes. Switching between deployment models is possible. We work with you to plan the migration according to your specific requirements and constraints.
No. Medioora supports unlimited projects, requirements, documents, and traceability links.
In addition to the software, the Enterprise package includes tailored consulting, training, requirements engineering support, project guidance, and direct access to experienced MedTech experts.
🔒 Security & Compliance
Medioora can be deployed either in the Medioora Cloud or on your own infrastructure. Organizations with specific security or compliance requirements can use the Self-Hosted edition and retain full control over their data.
Yes. Medioora was specifically designed for medical device development and helps teams meet regulatory requirements through structured documentation, version control, review workflows, and complete traceability.
All changes are versioned and can be reviewed through version history and visual diffs. This ensures full visibility into who made a change and how content has evolved over time.
Yes. Medioora includes a role-based access control system that allows permissions for projects, documents, and features to be managed with precision.
Yes. Regular backups are part of standard operations. For Self-Hosted deployments, backup strategies can be customized to meet your organization's specific requirements.
💬 Support & Onboarding
Cloud environments can be provisioned within a short time. For Self-Hosted deployments, we guide you through the setup process and support the technical implementation.
Yes. We support teams from the initial setup through onboarding and productive use. If required, we also assist with structuring requirements, documentation, and development processes.
Yes. We offer training for administrators, developers, project managers, and quality professionals. Training covers both the effective use of Medioora and proven requirements engineering practices.
Yes. Medioora can be flexibly adapted to existing development processes. Existing requirements, documents, and templates can be imported and reused.
Yes. Medioora is backed by MEDtech Ingenieur GmbH. For questions regarding the platform, regulatory requirements, or development processes, experienced MedTech experts are available to provide direct support.