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
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
At Cognition, the success of our customers is key. That’s why our latest product, Compass MED, was designed with 3
An introduction to how smart data utilizes information and actionable context to support business-critical decisions. It may sound fanciful to
Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to
Imagine developing a medical device or drug that could be claimed to work without any evidence…. And where profits could
There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and
Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483
