We’ve been in your shoes, staring down a new FDA regulation and wondering how big a disruption it will be.
Fortunately, if you are already marketing your devices internationally, the reality of the QMSR is far less dramatic than the headlines suggest. And with a modern QMS, it’s not just manageable; it can actually simplify your compliance work across multiple regulatory jurisdictions.
What’s Changing in the Regulatory Framework
The U.S. Food and Drug Administration (FDA) has issued the Final Rule that replaces the long-standing Quality System Regulation (QSR) established by 21 CFR Part 820 with the new Quality Management System Regulation (QMSR). This update harmonizes U.S. requirements with ISO 13485:2016, the current international standard for medical device quality.
This regulatory shift, published in the Federal Register, was designed to reduce duplicative requirements, streamline FDA inspections, and align with global regulatory authorities.
In practice, this means the FDA has incorporated ISO 13485 by reference, simplifying compliance with regulatory requirements and reducing regulatory burdens for global manufacturers while still ensuring the safety and effectiveness of every finished device governed under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Why This Change Matters
This move isn’t a five-alarm fire for compliance managers; in fact, it’s more of a natural evolution for quality system requirements.
For some, it even feels validating that all the hard work they’ve already put in to comply with global standards is now the norm:
Global Harmonization
The FDA recognized that ISO 13485 and the current good manufacturing practice (cGMP) requirements under the existing QSR were “substantially similar,” providing equivalent assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective. Meaning simpler compliance processes, for instance, under MDSAP (Medical Device Single Audit Program).
Consolidated Definitions
The legacy terms Device History Record (DHR), Device Master Record (DMR), and Design History File (DHF) are being consolidated into the Medical Device File (MDF). While the names change, the specific requirements for documentation and control of records remain equivalent.
Expanded Oversight
FDA inspections may now include previously exempted records. The FDA can now:
- Fully access management review records, including meeting minutes, decisions, and action items.
- Review internal audit records, including findings and methodologies.
- Examine supplier audit records, including audit reports, corrective actions, and supplier evaluations.
Greater Supplier Scrutiny
The QMSR and ISO 13485 framework place stronger emphasis on supplier qualification and vendor controls, requiring manufacturers to prove their extended value chain meets quality system requirements.
Risk-Based Approach
The new QMSR requirements reinforce risk management principles, making compliance more about thoughtful design controls and internal audits than box-checking.
International Advantage
Companies already operating under ISO 13485 or ISO 9000 will find the transition period to be relatively smooth. For newer entrants in the medical device industry or those that only market their devices in the USA, the change may feel more burdensome, but it’s ultimately beneficial.
Key takeaway: With the right QMS, the QMSR transition is more bark than bite.
5 Steps Medical Device Manufacturers Should Take Now
Even if the preamble makes it clear the FDA doesn’t want to add unnecessary burden, medical device companies should still act now during the transition period before the effective date of February 02, 2026:
1. First and foremost, ensure your eQMS is compliant. Before anything else can happen, your QMS needs to meet the new FDA regulations. Conduct a gap analysis assessment comparing your current eQMS against both QMSR and ISO 13485 requirements. With a modern platform, this step is effortless and makes it easy to streamline the rest of the update process.
2. Consolidate into the MDF. Ensure your QMS unifies DHF, DMR, and DHR into the new Medical Device File post QMSR effective date, while maintaining historical records, covering labeling, packaging controls, and combination products.
3. Update Documentation. Revise SOPs, templates, work instructions, quality procedures, and internal audit processes to reflect the new quality management system regulation, including design controls and management review practices. The terminology changes alone could require substantial documentation updates.
4. Educate and Train Stakeholders. Build awareness and retrain teams so every employee understands how QMS requirements are shifting.
5. Risk-Based Process Integration. The QMSR’s emphasis on integrated risk management throughout the quality system lifecycle may require process redesign for organizations that previously treated risk management as a separate activity.
Without a flexible system, these steps mean rewriting processes, revalidating systems, and retraining staff—sometimes in disconnected tools.
Why Legacy QMS Platforms Struggle
Older or hard-coded systems—built around outdated definitions of QS regulation and quality system requirements—will require costly reconfigurations to adapt. Some providers even sell additional requirements like training management as extra modules. That leaves quality leaders juggling compliance across disconnected platforms.
A rigid system turns every new rulemaking into a project. A modern QMS adapts as the rules change.
If your legacy QMS requires a system upgrade for compliance with QSMR, that necessitates significant efforts for re-validation. In contrast, modern eQMS software like Propel doesn’t require any software updates at all for the QMSR change; customers can keep using their current Propel version with only process updates.
How Propel QMS Transforms Compliance Into Competitive Advantage
Propel’s cloud-native QMS was designed for regulatory agility, making QMSR compliance a smooth transition rather than a fire alarm. Here’s how:
- Requirements Traceability – Ensure every stakeholder can link user needs to requirements, risks, and verification steps. Perfect for guidance documents and FDA inspections to establish traceability.
- Seamless Document + Training Management – Updates to controlled documents automatically trigger new training assignments. Unlike other systems, no separate add-on is required.
- Flexible Records Management – Keep historical records intact while creating new CAPAs or revisions without corrupting prior data. For instance, Propel can support your new MDF without requiring an update, while also maintaining historical records of DHR, DHF, and DMR. Critical for internal audits and supplier audits.
- Audit Trail Everywhere – From record-level to admin-level, Propel’s audit trail ensures transparency across the regulatory framework.
- Salesforce-Powered Flexibility – Create custom fields, flows, or automations to quickly adapt to new requirements. Legacy systems force you into reconfiguration or reimplementation; Propel adapts instantly.
- Built-In Product Data – Unlike standalone eQMS systems, Propel combines PLM and QMS in one platform. For example, UDI (Unique Device Identifier) requirements, part of both ISO 13485 and the new QMSR, can be managed natively, right alongside your product records, labeling, and packaging controls.
Why Regulatory Agility Matters
The medical device industry is facing constant change: shifting federal regulations, new consensus standards, evolving combination products, and stricter requirements for finished devices.
The next guidance documents or additional requirements could arrive at any time.
With Propel QMS:
- No costly upgrades just to stay compliant
- No reimplementation when terms like device labeling or packaging controls shift
- No scrambling when regulatory authorities refine QSIT inspection techniques
Instead, you gain a system that integrates seamlessly within your product lifecycle, always ready to evolve with new QMSR requirements, new FDA requirements, or requirements from international regulators.
Conclusion: Compliance as a Strategic Edge
The new QMSR is not just another regulatory hurdle; it’s a reminder that the regulatory landscape will always evolve.
Companies that stay stuck on inflexible systems will always be reacting. Companies that modernize their QMS will always be ready by future-proofing their systems to these regulatory shifts.
With Propel, compliance isn’t a cost center. It’s an advantage. By aligning with the final rule, meeting QMS requirements, and ensuring regulatory compliance without disruption, you free your teams to focus on innovation and patient safety.
Bottom line: In a world of constant change, a modern QMS isn’t just nice to have. It’s how medical device manufacturers stay ready for whatever the FDA or any other regulatory authorities require next.
