Starting on February 6th, 2026, medical device manufacturers will need to meet the FDA’s Quality Management System Regulation that incorporates the international standards for Quality Management Systems defined in ISO 13485:2016. This means the FDA is changing its inspection methods from the Quality System Inspection Technique (QSIT) that has been in use for over 20 years, and companies will need to prepare their quality system, their records, and their personnel to meet the FDA’s updated expectations.

While existing 21 CFR Part 820 regulations and ISO 13485 standards are generally similar, there are some significant differences in areas, including supplier management and risk controls. Changes are also going to allow FDA inspectors to look through Management Review records, internal audit findings, and other areas that were previously exempt from direct inspection.

Making the Quality Management System Updates

With the deadline only two months away, companies shouldn’t wait until the last minute. The main steps to making the Quality Management System updates include:

1. Perform a gap analysis between the company’s current quality management system documents and ISO 13485 requirements.
2. Update the quality management system to address the gaps identified in the analysis.
3. Implement required changes, train personnel on the updated procedures, and begin using the new procedures.
4. Perform internal audits to confirm that the updates have been effectively implemented.

Performing Mock FDA Inspections

Once the quality management system updates and internal audits have been completed, another great way to prepare for an FDA inspection is by holding a mock inspection. The primary goals of doing this should be:

1. To identify gaps in processes and in documentation.
2. To prepare the staff for an actual inspection.

The secondary goals should be improving the quality systems and verifying regulatory compliance. Understanding the distinction between primary and secondary will improve the overall results of conducting the exercise.

There are different approaches to conducting a mock inspection. On one extreme, everyone participating in the event is told that they should behave exactly as they would during an actual FDA inspection. The mock inspector stays “in character,” and the employees only answer questions exactly as they would in an actual inspection. What this method does well is to help prepare employees for the stress of an actual inspection. What it does not do well is identify gaps in processes or documentation because the inspector can only touch on a limited number of topics in the time allotted to the exercise. Employees are not encouraged to provide honest feedback on any areas that they knew might be problematic but would never have revealed in an actual inspection. Encouraging employees to keep a known problem hidden from the mock inspector does not benefit anyone and can result in something that should have been corrected going unchanged until it is identified by an actual inspector.

At the other end of the spectrum are mock inspections where the employees are encouraged to provide full details of any known problems with processes and documentation that were being reviewed by the mock inspector. This method is very good at identifying gaps, but it really doesn’t prepare employees for an actual inspection. Of the two extremes, the second method, the gap identification method, is more valuable. However, this approach should not stop there. The gap analyses of documentation and processes should occur as a routine practice through internal quality audits and periodic reviews of quality system procedures, and shouldn’t be an exercise that occurs only once every few years, just before an actual inspection.

The best approach is to ask employees to treat the mock inspection as a real inspection, but give them the ability to “call a timeout” so they can ask for a recommendation on how to answer a complicated or unclear question in case it does come up during an actual inspection. They should also be able to take notes so that if they are aware of a problem relating to the inspector’s question but were not directly asked, they can bring up the topic during the post-inspection discussions. In this way, the flow of the mock inspection can proceed with minimal interruptions, but areas that might need further review are identified and reviewed in greater detail after the inspection.

If the mock inspection achieves both the goals of preparing employees and identifying strengths and weaknesses within the quality system, then the post-inspection activities can include any additional preparation training necessary. Additionally, these post-inspection activities can also drive any additional updates that need to be made to improve documentation and ensure regulatory compliance.

Understanding the FDA’s Use of AI

In addition to the QMSR changes, the FDA has also announced that it has deployed agentic AI capabilities for all agency employees. While they haven’t announced specifically how AI will be used, the FDA’s press release on December 1, 2025, specifically mentioned the “use of AI to assist with more complex tasks, such as … pre-market reviews, review validation post-market surveillance, inspections, and compliance…”. With AI assistance, an FDA inspector will be able to review a greater number of documents quickly, searching for key terms and comparing company procedures against regulations and standards. With these changes, it will be more important than ever for companies to perform a thorough review of the quality procedures and records to identify possible problem areas and address them prior to an inspection.

Partnering with CieloWorks: We Can Help!

At CieloWorks, we offer tailored support to help teams at all stages navigate the transition. We can jump in to review your existing quality management system, helping you spot areas that need attention, whether it’s missing documentation, outdated procedures, or gaps in risk management. Once gaps have been identified, we can draft updates that align with ISO 13485 requirements and make sure your team knows how to implement them. We also assist with internal audits, perform mock FDA inspections, and provide training to prepare your employees for an FDA inspection. Ready to get started? Contact us today!