Microsoft, GitHub, and Azure DevOps: What the Shift Really Means – and Why Modern Requirements is Built for What’s Next
Explore how GitHub and Azure DevOps work together in a...
FDA QMSR and ISO 13485 Requirements Governance: What Medical Device Teams Need to Know
Listen to this blog
For years, medical device makers and sellers in the USA followed 21 CFR Part 820, known as the Quality System Regulation (QSR). Along with them, they were also required to follow ISO 13485, which is the main global standard for quality management systems for medical device companies. So, the real challenge was managing both separately.
To overcome those challenges, the U.S. Food and Drug Administration (FDA) has introduced QMSR (Quality Management System Regulation) in February 2024 to align FDA rules more closely with ISO 13485.
This change affects how requirements for medical device development are created, updated, documented, approved, traced, and maintained throughout the whole lifecycle. So, medical device developers need to understand how QMSR aligns with ISO 13485 and what next steps they should take.
What Is the FDA QMSR and How Does It Change Requirements Governance?
As mentioned in the introduction, the FDA QMSR is an updated framework to manage the quality of medical devices, a replacement for the FDA QSR to align them with ISO 13485. It became effective on 2 February 2026.
Here is what is updated in QMSR:
- Basic definition updates: QMSR uses terminologies that fit modern supply chains involving specification developers and contract manufacturers instead of just focusing on manufacturers. Other than that, 90% of definitions align with ISO 13485.
- More focus on risk management: QMSR puts more emphasis on risk management throughout the product lifecycle, instead of performing risk reviews just before production.
- Updates for data handling: QMSR forces teams to put more focus on electronic records and improve data integrity requirements.
- Requirements traceability: Now, requirements traceability must connect user requirements, design inputs, development tasks, user stories, verification results, and evidence during any medical device component manufacturing.
- Supplier controls: It covers rules about quality expectations while purchasing components from third-party suppliers.
- Enhancement of corrective action: It strongly enforces teams to review, investigate, and resolve issues with evidence.
This framework is designed to:
- Align US regulations with international standards.
- Reduce the burden of compliance on medical device manufacturers and duplicate efforts that were required to implement both regulations separately.
- Manage stronger traceability across the medical device development lifecycle.
QMSR and ISO 13485 Side by Side – Where Requirements Governance Overlaps
It’s true that QMRS and ISO 13485 are 85-90% aligned, but QMRS is not a replacement for ISO 13485. The FDA covers extra rules related to medical device inspection, labeling, and reporting rules that ISO 13485 doesn’t define explicitly. So, it is important to understand where both overlap and where it doesn’t.
Where QMSR and ISO 13485 Largely Align
- Risk-based decision-making: Both enforce teams to analyze the risk associated with product changes, supplier performance, complaints, and process failures and their potential impact on existing products before taking any actions.
- Both require CAPA: Corrective and preventive action covers how to identify root causes of issues, implement actions, and document effectiveness.
- Supplier management: External and third-party service providers or manufacturers should be qualified, monitored continuously, and re-evaluated after a specific time frame.
- Process validation: Both emphasize a strong focus on development process verification and validation. Also, it puts extra effort where results cannot be fully verified later through inspection or testing.
- Management responsibility: Leadership must show commitment to resource planning, reviews, and escalation of quality issues.
- Traceability and record retention: With reliable links between requirements, risks, tests, approvals, and released product records, teams can track development history.
Where Important Differences Still Remain
There are a few FDA-specific obligations that are not covered in ISO 13485. So, companies still selling in the USA market need to adhere to the following obligations:
- Follow FDA-specific rules for Medical Device Reporting and other statutory reporting duties outside the ISO certification scope.
- Organizations need to stay ready for inspections. The FDA has the right to request all records directly.
- Must follow labeling and packaging controls:
- Must use e-signature during reviews and approvals.
So, with this, teams can have a single framework to implement QMSR and ISO 13485 together.
The Most Common Challenges Teams Face While Implementing QMSR and ISO 13485
It is very important to showcase how requirements for medical device development are maintained throughout the product lifecycle in an audit report to achieve FDA QMSR and ISO 13485 compliance certification, but most teams struggle with that and generally face the following challenges:
- Vague requirements: When teams don’t convert QMSR or ISO 13485 obligations into actionable requirements properly, it often creates rework and introduces compliance gaps. Teams should use AI tools that take obligations as input and draft requirements without missing anything.
- Broken traceability: When ISO 13485 requirements traceability is not managed in a single place, teams miss links between business requirements, user stories, and evidence. This gap is enough to get rejected by regulatory bodies during the certification process.
- Inappropriate change control process: Feature requirements or documents always evolve, and every time, teams need to ensure they align with QMRS and ISO 13485. Even one Reddit user mentioned he is struggling to change SOPs 4-5 times a week. This happens when teams don’t have a single source of truth to manage all requirements and documents and a change control process in one place. To solve this, every change must be traceable, documented, and approved with e-signatures.
- CAPA and complaint data not feeding requirements: Recurring complaints or nonconformances should trigger requirement review. In many companies, CAPA data sits in one system while product requirements sit elsewhere, so lessons learned never reach development.
- Weak ownership and slow approvals: When a clear owner for requirements, a clear baseline to start implementation, and an approval workflow are not in place, teams end up developing non-compliant medical devices.
In the next section, let’s look at how to overcome these challenges while developing medical devices.
How Modern Requirements4DevOps Supports QMSR and ISO 13485 Compliance
Modern Requirements4DevOps is a medical device requirements management tool that helps organizations to maintain FDA QMSR and ISO 13485-related requirements device development requirements directly within Azure DevOps. So, teams can have a single source of truth to manage compliance and development.
Furthermore, QMSR enforces teams to implement end-to-end bi-directional traceability, and Modern Requirements4DevOps automates that within Azure DevOps. By creating traceability matrices, teams can visualize how compliance is connected with user stories, tests, evidence, etc., and visualize what is implemented and what is missing.
Also, QMSR expects medical device teams to make risk-based decision-making. For that, Modern Requirements4DevOps offers Agent4DevOps, which allows creating agents that analyze the risk score of requirements when they are created or updated and instantly notify teams about critical situations.
With AI impact assessment, teams can analyze how changes in any device requirement can affect compliance. Also, the built-in review management workflow allows teams to approve requirements with e-signature, which is most important to stay compliant with QMSR.
Copilot4DevOps AI can be used to draft medical device development requirements based on QMSR and ISO 13485 obligations. So, teams can cover all requirements without any compliance gaps.
Moreover, instead of preparing for audits through manual document assembly, it allows teams to prepare audit reports with a single click and maintain readiness as part of normal development work.
Índice
Artículos recientes
Webinar – AI for Requirements Engineering in Medical Device Development
Design controls, validation, and audit readiness – solved. How Copilot4DevOps...
Webinar – AI for Requirements Engineering in Large Defense Systems
Discover how AI enhances traceability, speeds analysis, and reduces risk...
