Empowering Biopharma and MedTech Product Development with Enhanced Quality, Compliance, and Efficiency
Streamline workflows, ensure regulatory readiness, and unlock the full potential of your data with Compass
your trusted solutions for structured data, traceability, and submission-ready documentation.
Structured Content and Data Management and Design Controls
Cognition’s innovative out-of-the-box SaaS solutions address the needs of both the Biopharma and MedTech industries.
Compass BIO enhances structured content and data management by providing a unified platform to capture, organize, and track critical information throughout the product lifecycle, ensuring compliance and streamlining regulatory submissions in the biopharma industry.
Compass MED simplifies design controls by offering robust tools to manage design inputs, risk assessments, and testing requirements, ensuring that all medical device development activities meet regulatory standards.
Our solutions help Biopharma and MedTech companies improve efficiency, reduce risk, and accelerate time to market by maintaining clear, traceable documentation throughout the entire development process.
Embrace Quality by Design (QbD)
Effortlessly integrate quality into every phase of product development, ensuring compliance and minimizing risk from the outset. By proactively addressing potential issues during design, our solutions help reduce costly delays, improve product consistency, and enhance patient safety. Additionally, QbD accelerates time to market by streamlining the regulatory process with documentation and reporting tools that are ready for submission, leading to faster approvals and fewer regulatory hurdles.
Trusted By
Enhance Development – At Every Step
It’s never been both more challenging and more important to bring medical devices and pharmaceuticals to market faster. Our solutions can help. With change once, update everywhere functionality, guided workflows, real-time traceability, submission-ready documents, and more—we’ll increase your efficiency while ensuring data integrity, chain of evidence, and compliance.
Unlock Collaboration
A manual approach to product development—relying on Excel, Word, or paper—elongates processes and increases the risk of errors. We provide an information-driven approach with both an intelligent document-centric and data-centric workspace across every functional area.
With more connected and consistent information, you’ll save time and resources while enhancing collaboration.
A Message from Our CEO
Maximize Efficiency
We automate, integrate, and enhance processes throughout the development process, so that you can reduce manual data entry, easily build connections between items, and automatically create complex traces.
With all your data in one system, you’ll gain a 360-degree view of your progress, as well as real-time and historical views of safety risks, process risks, requirements, quality attributes, testing, and more.
Streamline Audit and Submissions
With integrated data, you can start automatically compiling, in parallel, what’s needed for regulatory approvals sooner—speeding your time to submission. Further accelerate your processes with submission- and audit-ready reports that can be exported instantly.
Plus, by using our guided workflows and templates to ensure compliance with Biopharma standards ICH Q8, ICH Q9, ICH M4, FDA Part 11 and MedTech standards ISO 14971, ISO 13485, and 21CFR820.30 and—you’ll gain more regulatory approvals upon first submission.
What Customers Say
Ian Bennett, IT R&D Leader, Smith & Nephew