A medical device quality system should do more than keep procedures, forms, and records in one place. It should show how a product is designed, made, tested, supplied, monitored, and improved. When a company sells in several countries, the challenge is keeping these activities consistent while still meeting the requirements of each market.
This is particularly important in 2026 because the FDA’s Quality Management System Regulation (QMSR) is now in effect. QMSR became effective on February 2, 2026, and incorporates ISO 13485:2016 into 21 CFR Part 820. The FDA made this change to bring its device quality requirements closer to the international quality management framework used by other regulators. At the same time, the FDA replaced its former QSIT inspection approach with the inspection process described in Compliance Program 7382.850.
For manufacturers, this does not mean starting from scratch. It means taking a close look at the existing quality system and making sure it works under the current U.S. requirements as well as the rules of other markets.
How QMSR Fits With Global Quality Requirements
Many medical device manufacturers already use ISO 13485 as the basis of their quality system. Under QMSR, ISO 13485:2016 is incorporated into the FDA framework, while Clause 3 of ISO 9000:2015 provides related quality-management terminology.
This can help companies use one core quality system across markets, but ISO 13485 certification alone does not confirm full QMSR compliance. A gap assessment should compare existing procedures, records, responsibilities, and practices with the applicable requirements.
Global Requirements
A company selling medical devices in different countries may need to meet additional requirements for labeling, reporting, registration, traceability, and records. Manufacturers can keep their main quality processes consistent and add market-specific requirements as needed. This allows manufacturers to maintain one core QMS without overlooking local regulatory requirements.
What Manufacturers Need to Change
For companies that already have an established ISO 13485 quality system, many existing processes may remain useful. The important task is identifying where changes are needed rather than rewriting everything. A review should cover the following:
- Current procedures and work instructions.
- Document approval and revision controls.
- Training records linked to updated procedures.
- Quality records created before and after February 2, 2026.
- Areas where FDA-specific requirements need to be added.
Document control is one area worth reviewing carefully. Procedures should reflect current requirements; employees should know which version is approved, and older documents should be removed from active use.
Records also deserve attention. The FDA states that investigators may review quality system records created before February 2, 2026, to determine compliance with QMSR. The agency recommends that manufacturers be able to show how older documents and records meet the current requirements.
This information makes a documented comparison valuable. It can show what was reviewed, which gaps were identified, and how the company addressed them.
Key Quality Areas to Review Under QMSR
A QMS needs to work across the activities that affect product quality. Design decisions, suppliers, production, complaints, corrective actions, and management review should not operate as separate processes. The records from one area may be needed to understand or resolve an issue in another.
- Design and Risk Management
Design and risk management should remain closely connected throughout the product life cycle. A change to a material, component, software, or manufacturing process can affect product performance and existing risk controls.
The company should be able to show why a change was made, how its effect was reviewed, and whether additional testing or risk assessment was required. The FDA has specifically addressed risk management, risk-based decisions, and design and development in its QMSR implementation guidance.
- Supplier Controls
Suppliers can directly affect the quality of a medical device through materials, components, software, testing, sterilization, packaging, and other services.
Supplier controls should cover approval, monitoring, performance review, and action when requirements are not met. The level of control should also match the importance of the supplier’s product or service.
Under QMSR, FDA investigators can review supplier audit records, along with quality audit and management review records. This makes complete and well-maintained supplier records especially important.
- Complaints and CAPA
Complaints can provide information about problems that design or production may not have identified. A repeated complaint may point to an issue with the device, manufacturing process, supplier, labeling, or user instructions.
Complaint information should therefore connect with nonconformities, risk management, and CAPA. When a corrective action is taken, the company It should be able to show the cause of the problem, the action taken, and whether the action was effective.
- FDA Inspection Readiness
The FDA replaced QSIT with Compliance Program 7382.850 when QMSR took effect on February 2, 2026. The current approach uses a risk-based inspection process and can involve review of connected quality-system activities.
Manufacturers should be prepared to explain how their quality system works and provide supporting records. An issue in one area may lead to questions about another, so records should be complete, consistent, and easy to retrieve.
When the QMS Needs Review
A quality system should be reviewed when there are changes to the device, manufacturing process, suppliers, regulations, or internal procedures. Regulatory requirements can also change after a product is already on the market, so companies need a clear way to identify new requirements and decide whether updates are needed. Regular review can help check whether,
- Procedures still match current requirements.
- Employees have completed required training.
- Changes have been properly reviewed and approved.
- Quality records remain complete and accessible.
- Previous corrective actions continue to work.
This does not mean changing procedures unnecessarily. The aim is to keep the quality system accurate, useful, and aligned with the work we perform.
Wrapping It Up
A good QMS should fit the way a company works and make quality responsibilities clear. With QMSR now in effect, manufacturers can review their current systems, address any gaps, and maintain a common approach across different markets. The aim is to have a quality system that supports day-to-day work and remains ready for regulatory review. Regular review also helps companies respond to changes in products, processes, and regulatory requirements. A practical system is easier for employees to follow and easier to maintain over time.
