FDA | requirements | design controls | Medical Device | Product Development | Industry Updates | Design | Compass MED
In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA finalizing the alignment of its Quality System (QS) regulation with ISO 13485 by February 2026, medical device companies need to act now. This alignment has been expected as the international standards and FDA regulations have been converging for Quality System expectations for years. Since FDA announced its intent to align with ISO 13485 in 2018, the change should not be a surprise to medical device companies, but the implementation still requires careful and detailed attention to specifics. Fortunately, solutions like Cognition Corporation’s Compass MED provides a proactive way for companies to navigate complex regulatory landscapes and stay compliant from the start.
Why Start Preparing Now?
Detailed changes can be easier to implement with the help of tools to meet regulatory standards. Compass MED’s structured data and design control SaaS solution takes ISO 13485, FDA 21 CFR Part 820, and other international standards as the foundation of its software design, so it can be used to comply with these changes. It guides the overall content needed for the life cycle of the device, including what’s needed for audits. Device design evidence, such as planning documents, design requirements, risk analyses, and testing management, is contained within the software. Since its core engine leverages an innovative database for structured content and data management, changes to document formats or data output become efficient, and complying with changing regulations becomes simpler.
Who Does this Affect?
The aligned Quality Management System Regulation (QMSR) applies to the same groups that the current QS regulation applies to, from manufacturers to design developers. Component manufacturers aren’t currently included but may want to voluntarily comply with the QMSR because FDA may extend the rule to include them later, and medical device manufacturers may require key suppliers to comply with the same regulations that they do.
For multinational medical device companies that already sell their products in other countries aligned with ISO 13485, the changes to the US regulation likely make little difference. However, for companies only selling in the United States this may be more of a change. Plus there are details all medical device companies should be aware of as they go through plans to comply with this update, from terminology to inspections.
Essential Terminology Shifts in FDA's QMSR
Some of FDA’s terminology has been changed for consistency with ISO 13485’s terminology. For example, references to Quality System or Quality System Regulation have been updated to Quality Management System Regulation (QMSR) to more accurately reflect the holistic approach of ISO 13485. In another example, “device master record” (DMR), “design history file” (DHF), and “device history record” (DHR) do not appear in ISO 13485, which contains requirements for a “medical device file” (MDF). FDA has eliminated the earlier terminology.
How Compass MED Can Help
To stay compliant, medical device companies should start by reviewing existing documentation and updating terms like “design history file” to “medical device file.” By using built-in document templates, Compass MED can help streamline this process. Document templates can be aligned to product families or organization, while new projects are created with unified terminology and formatting built into the system. Since the underlying data is in a database that leverages structured content and data management, data can be pulled into new outputs, saving time and attention, eliminating manual errors and the need to recheck the data content as they are the same objects.
Global Harmonization: What It Means
Global harmonization helps medical device companies by streamlining regulatory requirements and removing unnecessary duplication of effort. Yet the overall goal is clarity, not efficiency. FDA is not streamlining to the point of adopting everything in ISO 13485 completely; keep in mind that if there are any conflicts between US regulations and ISO 13485, the FD&C Act and FDA regulations maintain priority. Some key requirements that are unique to the US, such as device labeling, complaint records, service records, confidentiality, and Unique Device Identification remain intact in this rule change.
Also note that global harmonization is an ongoing process: in the future when the ISO standard is updated, FDA will initiate a new notice-and-comment rulemaking to update the QMSR to incorporate the changes.
How Compass MED Can Help
Cognition monitors upcoming regulatory changes and provides updates to Compass MED as part of its SaaS software subscription in order to remain aligned with FDA and other regulatory bodies. Cognition always announces revised versions with expected changes in advance. Cognition’s implementation process helps companies remain in compliance with their own validation process as upgrades are not applied until approved by the customer.
Simplifying Compliance Through Built-In Traceability
Documented traces are currently viewed as a best practice in FDA’s quality system regulation to enable seeing the links between design inputs, outputs, design verification testing, and design validation. However, ISO 13485 goes beyond best practices and requires traceability in product planning. Different types of traces exist in device development overall, from simple assurance that the outputs meet the inputs, to risk traces to confirm that all mitigations are addressed, to test traces to confirm that all requirements have coverage, to manufacturing lot tracing of materials, process, and personnel.
How Compass MED Can Help
While detailed design traces could be a major change for manufacturers to implement effectively, the process is made much simpler with Compass MED, where tracing is built into the software. Compass MED connects and manages information, automatically signaling any missing connections, from user needs all the way through to verification tests. Traces are automatically updated as data is edited, ensuring that there is a single source of truth with no need to manually hunt down and change information in multiple places.
Risk Management: The Core of Compliance
FDA states in their rule change that ISO 13485’s incorporation of risk management throughout the product life cycle influenced the development of the QMSR. In addition, it’s important to note that ISO 13485 itself relies on ISO 14971 for the definition of "risk,” which is focused on the probability and severity of harm. For now, FDA is not adopting ISO 14971 in this rule of law; however, ISO 14971 has long been a registered consensus standard. FDA acknowledges that ISO 13485's conception of risk includes safety or performance requirements and applicable regulatory compliance beyond the cursory definition previously embedded in the regulation. It has frequently been best practice for most medical device companies to apply ISO 14971 to their risk management process.
How Compass MED Can Help
Compass MED is built to be aligned with ISO 14971, so employing this software provides the advantage of aligning with regulation and ISO standards and therefore enabling a risk-based approach to inform decision-making. Compass MED fosters the entire team to think about harms and mitigations throughout the design process due to the integration of risk, leading to improved safety by design.
Inspections and What to Expect
Inspection audits are not directly internationally equivalent. FDA’s quality audits have historically not recognized ISO 13485 certification by EU notified bodies as they don’t consider them as comprehensive as FDA inspections. However, FDA does recognize the Medical Device Single Audit Program (MDSAP), and therefore through compliance with this program, ISO 13485 and FDA regulations are acknowledged without further surveillance inspections required.
In addition, certain elements of ISO 13485, such as management reviews, internal audits, and supplier audit records were previously exempt from FDA inspections. These records are generally evaluated in the EU and other aligned single audit programs, and therefore FDA is now coordinating. By complying with this alignment, the company is always audit-ready for FDA, EU notified bodies, or others.
How Compass MED Can Help
By using Compass MED, all documents have a clear history of changes, electronic signatures for review and approval, and exportable formats with no post-processing. This makes sure that even if multiple software document management systems are used, the documents originate from a single controlled source of truth and can be exported as a non-editable PDF. By keeping the design data within Compass MED, companies can be confident during audits that the correct version is accessed and referenced and that all the data is traceable and aligned. Even with shifting audit expectations, Compass MED ensures that the right data is always available at the right time.
Conclusion
The regulatory landscape evolves and so do devices. There are lots of details to monitor in a regulated environment and it is important to not forget anything in efforts to align with regulatory agencies. Working with a system like Compass MED that has data and design control working together in one place, where changes can be incorporated and tracked easily, makes the process of regulatory compliance simpler and more efficient, even when standards change.
As FDA’s compliance deadline approaches, now is the time to confirm your company is prepared. Schedule a demo of Compass MED today and see how it can streamline your path to compliance, no matter where you are in the product life cycle.
