5 Design Control Gaps the FDA Will Target Under QMSR
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how
In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA
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
Most medical device manufacturers continue to rely on manual and Word/Excel-based approaches for design control and risk management—and that’s hindering
A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the
Critical Software Functionality for Every Medical Device Development Company Medical device development companies are increasingly recognizing the value of a
Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality
When it comes to medical device development, efficiency, speed, and accuracy are gamechangers. The faster you can move without sacrificing
