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
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
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
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
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
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
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
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
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
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)
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,
