Requirements management for medical devices - easy to use

  • How design input and output is structured
  • Traceability and audit logs are maintained
  • Risks are recorded
  • Test execution can be done
  • Reports allow to analyze the project
  • Documents generators allow to create technical files

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

How it Works

We help you to design your project

Projects in Matrix Requirements Medical can be configured to collect 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 covering hard 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 you can start entering all you already know.

You distribute the work

You can either just send out links to work items or link up with agile project management tools like JIRA or Pivotal tracker

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 which need to be controlled. You can flag items as reviewed once you are done with them.

You create the documentation for certifications

Creating up-to-date documents is easy: you create templates with the static content like change log, purpose, scope and signature tables and you add sections to extract data from the database, like simple design input, trace tables or test results. These documents can be archived and electronically signed which makes 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 traces connect items and how you can use them to navigate in the project. You can learn how the software indicates that these traces are missing or out of date and how to inform your team about it. It also shows some reports which helps your to verify and document the traceability.
  • 03

    Reports

    Learn how to select which items to include into reports and how to choose whether to create it as HTML, Word or PDF. See some examples of the default reports which can be generated: to document the design, create test instructions and document test results, do a risk analysis and traceability analysis and reporting and finally to help you to do and document design reviews.
  • 04

    Access Control and Versions

    This video shows how every change to an item creates a new version of the items. It shows how to look at and restore previous version 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 instruction 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 to your private instance.

Try it out NOW!

Test our live demos

Basic Configuration

Shows:
  • a basic setup with one 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
Try here

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
Try here

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, like regression and unit tests
Try here

Find out more about our product

See the features in detail
© 2017 All rights are reserved, v This site uses cookies... learn more Legal / Impressum