Cognition for MedTech Quality and Regulatory Teams
Move beyond document management to true quality management with a trusted solution for MedTech compliance.
Compass® MED: Simplify Quality, Regulatory, and Compliance Management
Delays, failed submissions, audits — these are not just minor stumbles along the way to market. They can be a major disruption for operations and your bottom line. For the teams that ensure a medical device’s quality and regulatory compliance, the stakes are high. Disconnected data and documentation further complicate an already difficult endeavor.
Shore up your data integrity and take the smoother path to market with Compass MED, Cognition’s out-of-the-box design control solution specifically designed for medical device manufacturers.
Manage Risk At Every Step
Faster Filing
Get Audit-Ready In No Time Flat
Schedule Your Compass MED Demo
Key Features for MedTech Quality and Regulatory Teams
Automated trace matrices and guided templates help stomp out disconnected data and documentation errors
Instantly generate submission- and audit-ready reports, consistent between internal data and exported documents
Easily access guided workflows for complete compliance with ISO 14971, ISO 13485, and 21CFR820.30
Use built-in templates for risk management planning, preliminary hazards analysis, use error analysis, FMEA, and product risk analysis
Seamlessly integrate data and documentation linkages, and embed regulations and standards so that your documentation is always in sync with your design
Compass MED + AI:
Accelerate your operations with AI capabilities, woven directly into Compass MED. Deeply integrated with a mature, engineering-focused AI platform, Compass MED features a seamless and persistent intelligence layer to:
Compass MED Enables Your ALM Process
Application Lifecycle Management is a critical part of software development, but it’s often retrofitted into the development lifecycle of medical devices. Compass MED integrates your software development team—and the tools they’re already using—into the larger framework of medical device development.
Compass MED supports key steps in the ALM process:
Compass MED is an easy fit for your software development ecosystem
Jira integration
Easily works with your CI/CD platforms for software development
Pull and push data from repositories like GitHub, GitLab, and Devops
What MedTech Quality and Regulatory Teams Are Saying
“Cognition’s solution ensures teams spend significantly more time focused on productive
work, rather than building and maintaining documents and complex traces. This allows us to run lean and still accelerate our time to market.”
Chris Henry
Senior Manager, Software Quality and Engineering | Epic Sciences
MedTech Success Stories
Explore how quality, regulatory, and compliance leaders drive consistent success with Compass MED.
Cognition: A Trusted Partner for MedTech Innovators
With more than 20 years serving medical device companies, Cognition’s solutions offer innovation backed by decades of trusted support for leaders in the industry. Compass MED is tailored to solve real-world challenges faced during the medical device product development lifecycle, boosting efficiencies and ensuring safety and compliance at every step.
Greater Confidence Starts With Compass MED
Book your demo to see Compass MED, our purpose-built MedTech solution, for yourself.