Traceability Is the New Language of Regulatory Trust: Most Risk Files Still Don’t Speak It
Last month, Cognition sponsored and attended the International MedTech Safety Conference 2026 (IMSC26) at Northeastern University in Boston. Organized by
Last month, Cognition sponsored and attended the International MedTech Safety Conference 2026 (IMSC26) at Northeastern University in Boston. Organized by
How Usability Engineering and IEC 62366-1:2015/AMD1:2020 Compliance Drive Safer Devices and Faster Time-to-Market The Stakes Have Never Been Higher Medical
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how
Artificial intelligence (AI) is reshaping how products are designed, built, and brought to market. From automating routine tasks to providing
Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of
In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA
Our latest solution, Compass MED, is a structured data and design control SaaS solution built specifically for medtech companies. Key
In today’s rapidly evolving medical device industry, more companies and entrepreneurs are turning to contract design and manufacturing firms to
Medical device manufacturers face significant pressures to bring safer products to market faster. However, meeting critical project milestones and launch
How can medical device manufacturers successfully balance the significant pressures of today’s market? On the one hand, they need to
