This year, medical device OEMs face greater pressure and accountability to prove they are managing supplier risk. With the FDA’s Quality Management System Regulation (QMSR) effective February 2, 2026, risk-based thinking now runs through the quality process—and manufacturers need to be prepared to demonstrate how they are managing risk across their supply chain. The MedAccred® program provides a powerful way to strengthen oversight by independently verifying critical manufacturing processes are controlled and repeatable. 

The QMSR expects supplier controls to be risk-proportionate (ISO 13485, Clause 7.4)—and, for the first time, the records that show how an OEM exercises that oversight—supplier audit reports, internal audit results, and management reviews—now fall within the scope of an FDA inspection. The QMSR removes the long-standing exemption that previously kept these records off-limits, so thinly documented supplier oversight is no longer just an internal gap; it is now visible to the regulator.  

QMSR applies directly to finished medical device manufacturers, not to suppliers automatically. It aligns U.S. medical device quality requirements with ISO 13485:2016 by reference, but it does not require every supplier to obtain certification. Instead, manufacturers must determine the level of supplier oversight based on risk—including how critical a component is, whether it affects patient safety, and whether it involves a complex or critical manufacturing process. 

That shift puts greater emphasis on what OEMs can demonstrate about their supplier controls. For supplier quality teams, it is no longer enough to have confidence in a supplier at a high level. The real question is whether the processes that matter most to product performance and patient safety are actually controlled. 

This is where MedAccred adds significant value. 

Consider processes such as sterilization, welding, injection molding, heat treating, or other critical manufacturing operations. These processes can directly affect the safety, reliability, and performance of a medical device. For higher-risk suppliers, OEMs need meaningful evidence that these processes are being performed consistently and effectively. 

The MedAccred program provides an independent, industry-led accreditation – an assessment of specific critical manufacturing processes. Expert auditors evaluate whether a process is controlled and repeatable against requirements developed by the industry itself—giving OEMs greater visibility and confidence where supplier risk matters most. 

For suppliers performing critical processes on components with direct patient contact or significant safety implications, MedAccred provides an additional layer of assurance that goes directly to technical process control. Rather than relying solely on a supplier’s broader quality documentation, OEMs gain independent verification of the process itself. 

And that matters more now. 

As QMSR raises expectations for risk-based supplier oversight, OEMs need a defensible way to demonstrate that the critical processes those suppliers perform are controlled. The MedAccred program helps provide that evidence while giving manufacturers a consistent, industry-driven approach to assessing high-risk processes. 

The result is stronger supplier oversight, greater assurance in critical processes, and an opportunity to reduce redundant audit activity across the medical device supply chain. 

Want to learn more? 

Discover how a MedAccred accreditation supports risk-based supplier oversight and helps manufacturers build confidence in critical manufacturing processes. Explore the MedAccred program today.