Compass MED

Compass® MED is a SaaS design control solution built for medical device manufacturers and contract design organizations. It covers the full medical device development lifecycle by integrating requirements management, risk management, and test management in a single platform, with the goal of reducing errors and accelerating time to market while meeting quality and regulatory standards.

The platform is developed by a team with more than 25 years of experience providing product development and technical SaaS solutions to the life sciences industry. It is intended for use across the entire MedTech team, including product teams, quality teams, R&D engineers, and organizational leaders.

Core Capabilities

• Unified platform: Requirements, risk, and test management are accessible in one environment, with risk management integrated into the design control process from the start of product development.
• Automated traceability: Trace matrices are built automatically as data is added, eliminating copy-paste errors and reducing the time required to construct large trace tables.
• Submission-ready documentation: With a single action, Compass MED generates documentation that is compliant with the user's QMS and applicable regulatory requirements.
• Flexible workspaces: Supports both tabular data-centric and document-centric workspaces, allowing users to work in the format that suits them without manual errors affecting data export.
• Real-time data filters: Allows quick review of information and connected items through automated trace matrices, ensuring data consistency across the platform.
• Integrated review and approval: Users can provide input into final documents directly within the software, maintaining data integrity and reducing reliance on external email or document tracking.
• Unified library with global updates: When data is updated in one project, all other projects using that data are updated automatically, reducing the need for manual cross-checking.
• Risk management: Supports pre- and post-mitigation risk assessment and links risk items with requirement items for verification of implementation, covering relevant risk standards and regulations.
• Audit and submission preparation: QMS- and regulatory-compliant documents, reports, and trace matrices are generated through customizable templates, providing properly formatted and approved outputs for internal use and downstream submission.

AI Capabilities

• Compass MED includes an integrated AI layer described as deeply connected with an engineering-focused AI platform.
• AI features are designed to accelerate engineering insights, support traceability and compliance, and enhance collaboration across the product lifecycle.

Workflow and Collaboration Features

• Supports verification and validation test cycles by enabling engineers to collaborate within the same platform.
• Reduces time spent tracking down emails and documents through in-platform review and approval workflows.
• Designed for quick implementation and customization to fit into existing team workflows.

Compass MED is delivered as a SaaS solution and is designed to support the full range of roles involved in bringing a medical device to market, from R&D and product development through quality assurance and regulatory submission.