Medical Device R&D Management and Regulatory Compliance Software

Compass® MED: Accelerate MedTech R&D and FDA Submissions

Compass® MED is a MedTech product development software solution that helps medical device innovators get to market faster, with fewer risks.

Data Management

Simplify and strengthen structured data management throughout product development with change once, update everywhere functionality.

Regulatory Readiness

Proactively manage risks, meet complex quality and regulatory standards throughout R&D, and navigate regulatory audits with greater confidence.

FDA Submissions

Compass MED generates FDA compliance documentation in the proper, submission-ready format at the click of a button.

Expedite Your Path to Market

Fill out the form to schedule your Compass MED discovery call and software demo.

Unified Requirements, Risk, and Test Management Software

As a flexible, intelligent design control solution, Compass MED supports medical device R&D and Systems Engineering teams throughout the entire medical device product development lifecycle.

Requirements Traceability

By linking risk items with requirement items, Compass MED makes it easier for medical device R&D teams to verify implementation.

Risk Traceability

Compass MED automates traceability as data is added to eliminate copy-and-paste errors and help MedTech innovators manage risks at every step of product development.

Test Management

With Compass MED, MedTech R&D teams can collaborate through the same platform to accelerate testing throughout the product development lifecycle.

Regulatory Compliance and FDA Submission Management

Compass MED makes regulatory readiness part of everyday medical device R&D, so there are no roadblocks when it’s time for submission.

Compliance Templates

As an FDA compliance software, Compass MED’s templates accelerate the required documentation for submissions.

On-Demand Documentation

Generate compliance documentation at the click of a button. Compass MED makes medical device regulatory management simple.

Automatic Formatting

Compass MED helps dot your I’s and cross your T’s to get paperwork properly formatted for MedTech regulatory submissions.

Audit-Ready Reports

With Compass MED’s approach to risk management, it’s easier to have compliance reports ready when audits arrive.

Real Results with Compass MED Software

Compass MED has helped leading medical device teams accelerate the path to market with more efficient R&D workflows.

“Compass MED provides unprecedented visibility and control, helping us proactively identify and address issues before they escalate.”

“Compass MED helps us run lean and still accelerate our time to market.”

“Compass MED gives us clear traceability to ensure appropriate verification and validation. You don’t get that with spreadsheets and word docs.”

“Compass MED helps us overcome the increasing burden on medical device manufacturers to meet standards and regulations.”

“We used to manually create data and maintain connections in paper DHFs. With Compass MED, we can maintain large trace matrices much easier.”

Strengthen Design Controls and Regulatory Management with Compass MED

Schedule your demo and see how Compass MED can level-up your medical device product development.