Medical Device and Pharmaceutical Product Development and Compliance

The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how design controls are evaluated during inspections. As the FDA aligns 21 CFR 820 with ISO 13485, inspectors will move beyond checking whether design control documents exist. Instead, they will assess whether design controls function as a connected, traceable system that integrates risk management, verification, validation, and change control. Below are five design control gaps the FDA will increasingly target under QMSR, and why many medical device companies may not be prepared.

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.

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.

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:

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.

An introduction to how smart data utilizes information and actionable context to support business-critical decisions.

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

Imagine developing a medical device or drug that could be claimed to work without any evidence….

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?