Requirements management for medical devices - easy to use

  • How design input and output is structured
  • Traceability and audit logs are maintained
  • Risks are recorded
  • How verification and validation testing can be done
  • Shows how reports can be used to analyze project data
  • Generates documents that build technical files

... and flexible enough to meet your needs and workflow.

How it Works

We help you to structure your project

Projects in Matrix Requirements Medical can be configured to collate all your design input and output in customizable categories. You can define the required upstream and downstream traceability, as well as required design reviews and risk formulas according to your procedures. If you are unsure how to structure your project we can help with anything from simple setups to complex IEC 62034 setups covering both hardware and software.

You import all existing data

If your documents are well-structured you can import them using a simple web interface. If not, we can help you to convert whatever you have. If you are just starting to document you can enter all your previous work. You can also extract your official documentation from tools like Confluence, Team Foundation Services, Zephyr Tests or Pivotal Tracker.

You distribute the work

You can either send out links to work items or synchonize with agile project management tools like JIRA.

You review the project status

During the project you can create many different reports showing if there are gaps in your documentation or new risks that need to be controlled. You can flag items as reviewed once they are completed.

You create the documentation for certification and audits

Creating up-to-date documents is easy: you create templates with static content like change log, purpose, scope and signature tables and then add sections to extract data from the database, such as simple design input list, trace tables or test results. These documents can be archived and electronically signed, making it easy to manage multiple releases.

Usage

  • 01

    Requirements and Risk Management

    This video shows how items can be organized in a tree structure and links to these items can be embedded into documents or email. You can see how requirements are created and linked to specifications. It shows how risks can be defined and linked to mitigations. It also covers some design and risk analysis reports.
  • 02

    Traceability

    This video shows how design input and output is connected and how you can navigate in the project. You can learn how the software indicates when traces or items are missing or are out of date and how to inform your team. It also shows examples of reports that help you to verify and document the traceability.
  • 03

    Reports

    Learn how to select which items to include in reports and choose whether to create it as HTML, Word or PDF. See some examples of the default reports that can be generated: to document the design, create test instructions and document test results. Perform a risk analysis and traceability analysis report and finally learn how to prepare and record design reviews.
  • 04

    Access Control and Versions

    This video shows how every change creates a new version of the item. It shows how to look at and restore previous versions of the same item and where the revision number of a version shows up in reports. It explains the concept of session comments which allow you to use the same comment for multiple changes rather than entering a new comment for every single change.
  • 05

    Testing

    This video explains how to define test cases and how they can be run in multiple test cycles. Learn how to enter the test results directly into the software and how to create reports with the test results. It also shows the reports you can create to print test instructions and to verify that the test cases cover all requirements and risks.

All we need to get you started is an email where we can send you the link.

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Basic
Configuration

Shows:
  • a basic setup with a single level of design input and output
  • a typical setup for verification and validation tests
  • risk management configuration with naming according to ISO 14971
  • reports and documents
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Medium Configuration

Shows:
  • three levels of requirement specification
  • automatic marking of system requirements which act as risk controls
  • a more sophisticated risk configuration with automatic rules
  • specific fields for uploading files, e.g. CAD drawing to specification
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Complex Configuration

Shows:
  • how a setup can map to standards like IEC 62304
  • design reviews can be implemented
  • SOUP can be documented
  • labels can be used to distinguish between different kinds of test cases, for example regression and unit tests
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