The U.S. Food and Drug Administration (FDA) issues Additional Information (AI) Requests during the review of medical product submissions.
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
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
By Brad BerniaProject Manager/Software Engineer Hey there! If you’re working on a medical device and staring down the barrel of an FDA premarket submission, you’ve
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
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
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
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
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
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
By Brad BerniaProject Manager/Software Engineer Hey there! If you’re working on a medical device and staring down the barrel of an FDA premarket submission, you’ve
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
