The U.S. Food and Drug Administration (FDA) issues Additional Information (AI) Requests during the review of medical product submissions.
On February 3, 2026, the U.S. Food and Drug Administration (FDA) issued a revised version of its cybersecurity guidance for medical devices. While the technical cybersecurity expectations remain largely consistent
Cybersecurity for medical devices is required according to the U.S. Food and Drug Administration (FDA). Medical device manufacturers must comply with federal regulations. Part of those regulations, called quality systems
On June 27, 2025, the U.S. Food and Drug Administration (FDA) released its final guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The guidance
Collaboration delivers automated testing solutions for embedded and safety-critical applications. CriTech is proud to formally announce our partnership with Parasoft, a global software testing leader with a focus on automated
At CriTech, we are not just a software engineering company; we are your partners in innovation and compliance. I’m Bob Rajewski, founder and president, and I’m thrilled to share our
Hello again! Welcome to another exciting dive into the world of medical device software engineering. Today, we are going to explore how CriTech ensures your medical device software not only
Synopsis : The benefits of Independent Verification and Validation (IV&V) of medical device software are many. The purpose of this paper is to discuss the value of Independent Verification and
