Requirements management for medical device development.

Structure requirements, follow their relationships and review them in context. Medioora connects requirements, documentation and tests, giving developers, CTOs and quality managers a shared basis for their work.

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From requirement to verification

Which specification does a requirement belong to? Which test verifies it? Medioora keeps these relationships visible to engineering and quality management.

Structure requirements

Organise requirements in a hierarchy and edit their details in context, so developers can see how each requirement fits into the project.

Follow requirement links

Follow links between requirements and tests. When a requirement changes, these relationships provide a starting point for assessing the potential impact.

Connect specifications and requirements

Work on specifications and requirements in the same application, keeping related information accessible in context for engineering and quality management.

Review requirements together

Comment on and review requirements in context. Engineering and quality management can discuss questions alongside the requirement itself.

AI-assisted requirements work

Use AI assistance to draft requirements and check for potential gaps. Your team remains responsible for evaluating the results.

Getting started

Three steps to a shared workspace

Workspace setup, training and support as your project gets started. We agree the schedule around your templates, roles and processes.

  1. Step 1

    Set up your workspace

    Set up the workspace and import existing templates.

  2. Step 2

    Define roles and train your team

    Administrators, developers and quality managers learn how to work with roles, permissions and everyday workflows in Medioora.

  3. Step 3

    Start working with your requirements

    Work through the first requirements together and resolve questions about using Medioora.

Frequently asked questions

Answers for developers, CTOs and quality managers.

For developers, CTOs and quality managers working in medical device development. Medioora connects requirements work with documentation, reviews and links to tests.

Requirements, specifications, tasks and tests, with version control and history. Links and reviews help your team work on these items in context.

Existing templates can be imported and used in your workspace. We discuss which templates you want to bring over during setup.

Engineering and quality management can comment on and review requirements in context and follow links to tests. Your team remains responsible for evaluating and approving the content.

All frequently asked questions