COMPASS® MED

Compass MED Data Management and Design Controls Software for MedTech Industry

Improve Efficiency. Incorporate Quality by Design. Enhance Risk Management and Compliance.

Compass MED is an intelligent solution for all your design control needs—including multi-level requirements management, comprehensive risk management, and test management. 

Specifically engineered for medical device manufacturers and contract design organizations, Compass MED increases efficiency and enhances data integrity. It offers real-time traceability, work instructions that accommodate guided compliance processes, submission-ready documents, change once—update everywhere functionality, and more.


What Customers Say

The increasing burden on medical device manufacturers to meet standards and regulations is a challenge without a tool such as Compass MED. Having a centralized system improves the efficiency of data management, allowing users to build and challenge their data and assumptions more effectively. Compass MED is the only way to go for device development.”

Natalie McRoberts
Co-founder
One of the biggest benefits of using Compass MED is the traceability within the design documentation. When you’re using Excel files and Word documents, the linkage is not clearly evident to the designer and the development team or the sustaining team supporting the product while in market. Having that clear linkage helps to ensure that appropriate verification and validation are completed during the design and development phase of the product.”

Julie Whalen
Global Quality Senior Leader, Design Controls
Compass MED is a revolutionary solution for medical device development. Its advanced capabilities enhance collaboration, efficiency, data integrity, and risk management, helping companies reduce time to market while ensuring compliance with the highest quality and regulatory standards. With its robust risk management features, Compass MED provides unprecedented visibility and control, enabling organizations to proactively identify and address potential issues before they escalate. Compass MED has transformed product development. This product doesn’t raise the bar, it sets a new bar for the industry.”

Nathan Brown
R&D Fellow

Cognition is Integral to Our Documentation

With Cognition, We Were Two Weeks Ahead of Schedule

Cognition Provides Cross-Functional Global Processes

Cognition Provides a Collaborative and Integrated Solution to Increase Efficiencies

Cognition Provides Powerful Requirements Management with Risk Management

Designed Specifically for Medical Device Development
Comprehensive Risk Management

Compass MED provides medical device companies an advantage with its risk-focused approach that places high emphasis on the value of tightly integrating risk management in the design control process with requirements and tests from early on in the development process. Compass MED supports pre- and post-mitigation and the risk management process defined in ISO 14971. It has the ability to embed global and/or regional regulations and standards to guide users through the risk analysis process. The out-of-the-box templates in Compass MED ensure process consistency by guiding users through the proper steps that produce comprehensive and useful assessments. Risk becomes an active part of your development process through integration with requirements and testing, far more than just a traditional “check the box” exercise.

Structured Data – Integration of Libraries Across Projects

Structured data contains specific information, each with a unique identifier. For structured data to be valuable, it may be used in multiple locations, exist over time, be reusable, be connected to child/parent/peers, and enable action at a distance. Given the unique ID setup, if you need to update the central property, the update will be pulled or pushed through to all locations that use it. This is exactly how Compass MED treats your product development data.

Structured data has many benefits, including:

  • Establishing a single source of truth
  • Increasing compliance
  • Reducing errors
  • Reducing time-to-market
  • Improving data integrity
  • Reducing resource costs
  • Reducing IT burden
  • Increasing report quality
  • Preparing for the future
Traceability
Dashboards, Reports, and Personalized Landing Pages
Flexible Workspaces
Streamline Audits and Submissions
Process-Based, Out-of-the-Box Functionality

Compass MED Demo Series

Ready to learn more about our design control solution? Fill out the form for access to our on-demand series:

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Connect with Cognition

Meet with David Whitney, Vice President, Medtech to learn how Compass MED can accelerate your device development journey.