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
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
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
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #13: Incomplete Software Requirements Documentation You provided Software Requirements Specification (SRS) documentation in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #14: Inadequate Risk Management Information You provided Risk Management File documentation in your
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #15: Inadequate Information on the Confidentiality Controls used to Protect the Device You
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #16: Missing Cybersecurity Risk Assessment Documentation Based on the information provided in your
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #17: Lack of Documenting the Final Version Number of the Software and Firmware
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #18: Off-The-Shelf Software In your software description, you provided information about the OTS
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #19: Missing Adequate Information on the Availability Controls used to Protect the Device
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided in your submission, your device meets the definition of a cyber device under Section
Here’s this week’s example of an Additional Information Request (AI Request): Your submission documentation indicates that you are using YYY as the operating system (OS) for the device. This OS
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided, it is not clear how the device detects, monitors, logs, and/or alerts users of
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
