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
The U.S. Food and Drug Administration (FDA) issues Additional Information (AI) Requests during the review of medical product submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs),
Additional Information (AI) Requests are a part of FDA’s procedure to provide a medical device company with an opportunity to submit additional information missing from the initial submission. This information
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #3: Missing Software Bill of Materials (SBOM) Based on the information provided in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #4: Missing Software Version History You provided some software version history documentation in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #5: Missing Observed Results in Test Logs You provided software testing as part
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #6: Information on OTS used in the Device is Contradictory You provided documentation
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #7: Missing Software Unit Testing FDA is unable to locate the unit testing
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #8: Missing Version of a Test Referenced in a Report The XYZ Software
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #9: Missing Documentation on the Cybersecurity 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 #12: Missing Documentation on Differentiating Privileges Based on User Roles Required to Protect
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
