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.
Out-of-the-box SaaS Solutions for Biopharma and MedTech
Compass BIO enhances structured content and data management by providing a unified platform to capture, organize, and track critical information throughout the product development 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.
Cognition’s 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.
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Improve Development – At Every Step
It’s never been more important and more challenging to bring medical devices and pharmaceuticals to market faster. Cognition’s innovative out-of-the-box SaaS solutions can help. With change once, update everywhere functionality, guided workflows, real-time traceability, submission-ready documents, and more—biopharma and medical device product development teams can increase their efficiency while ensuring data integrity, chain of evidence, and compliance.
Enhance Collaboration
A manual approach to product development—relying on Excel, Word, or paper documents—lengthens processes and increases the risk of errors. Cognition provides 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
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—accelerating your time to submission. Further improve your processes with submission- and audit-ready reports that can be exported instantly.
Additionally, the 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—you’re more likely to gain regulatory approvals upon first submission.
What Customers Say
Ian Bennett, IT R&D Leader, Smith & Nephew