Cognition Blog
Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.
FDA | requirements | design controls | Medical Device | Product Development | Industry Updates | Design | Compass MED
By:
Sally Carter
March 25th, 2025
In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA finalizing the alignment of its Quality System (QS) regulation with ISO 13485 by February 2026, medical device companies need to act now. This alignment has been expected as the international standards and FDA regulations have been converging for Quality System expectations for years. Since FDA announced its intent to align with ISO 13485 in 2018, the change should not be a surprise to medical device companies, but the implementation still requires careful and detailed attention to specifics. Fortunately, solutions like Cognition Corporation’s Compass MED provides a proactive way for companies to navigate complex regulatory landscapes and stay compliant from the start.
design controls | Testimonial | Compass MED | Traces
By:
Cognition Corporation
January 22nd, 2025
Our latest solution, Compass MED, is a structured data and design control SaaS solution built specifically for medtech companies. Key features include multi-level requirements management, comprehensive risk management, and test management.
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requirements | design controls | Design | Compass MED | Contract Manufacturers
By:
Patrick Maxwell
January 13th, 2025
In today's rapidly evolving medical device industry, more companies and entrepreneurs are turning to contract design and manufacturing firms to bring their ideas to life. Managing multiple products, teams, and clients simultaneously is nothing new for these firms; however, the increasing complexity of products and immense pressure on time to market demands a more robust approach. That's where a centralized, structured data management and design control solution purpose-built for MedTech such as Compass® MED becomes essential, enabling firms to efficiently organize and analyze the multiple streams of information involved. Here are six key benefits of using Compass MED:
design controls | Testimonial | Compass MED | Traces
By:
Cognition Corporation
September 26th, 2024
At Cognition, the success of our customers is key. That’s why our latest product, Compass MED, was designed with 3 key priorities in mind: Improve efficiencies, incorporate quality by design, and enhance risk management and compliance.
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