QMSR Compliance Services

Align your quality system with the FDA's new rule and stay inspection-ready in the US market.

The FDA's Quality Management System Regulation (QMSR) replaced 21 CFR Part 820 and now incorporates ISO 13485:2016 by reference, with FDA-specific requirements layered on top.

QbD Group helps medical device and IVD manufacturers assess their system, close the gaps, and stay inspection-ready — whether already ISO 13485 certified or building toward US market entry for the first time.

What is the QMSR?

The Regulation

The FDA's Quality Management System Regulation (QMSR) replaced the Quality System Regulation (QSR) under 21 CFR Part 820 and became effective on February 2, 2026. It now incorporates ISO 13485:2016 by reference, with FDA-specific requirements layered on top.

Scope & Supplemental Requirements

Any manufacturer selling medical devices or IVDs in the US — or planning to — must comply. The intent is harmonization with the international standard already used under the EU MDR, IVDR, and MDSAP.

An ISO 13485 certificate alone is not enough. The FDA has added supplemental requirements covering:

Device labeling and packaging controls (820.45)
Control of records (820.35)
Unique device identification (UDI)
Medical device reporting under 21 CFR Part 803

Inspection Program Update

On February 2, 2026, the FDA also withdrew its old inspection technique (QSIT) and began inspecting under a new, risk-based Compliance Program (CP 7382.850).

What changed. The FDA issued its final rule on January 31, 2024, replacing the QSR with the Quality Management System Regulation (QMSR). It was published in the Federal Register on February 2, 2024, and became effective on February 2, 2026 — the most significant update to US device quality rules since the 1990s.

Why harmonization is not enough. The intent is to align US requirements with the international standard used under EU MDR/IVDR and MDSAP. But an ISO 13485 certificate alone does not satisfy the FDA. The agency has added supplemental requirements covering labeling and packaging controls (820.45), control of records (820.35), unique device identification (UDI), and medical device reporting under 21 CFR Part 803. The FDA will neither require nor issue certificates of conformance.

Inspections have changed too. On February 2, 2026, the FDA withdrew its old QSIT technique and began inspecting under a new risk-based Compliance Program (CP 7382.850).

Three distinct starting points for manufacturers selling into the US:

ISO 13485 certified

Confirm your system meets the FDA's added expectations — not just the standard.

QSR-only legacy

Adapt your existing QSR processes to the new ISO 13485-based structure.

New US entrant

Build a QMSR-compliant quality system from day one.

Need help with QMSR compliance?

Our QA experts are ready to assess your system, close the gaps, and get you inspection-ready.

Get in touch

Why QMSR compliance matters

For manufacturers selling into the US, the QMSR creates three distinct starting points — and one shared destination: a quality system that holds up under FDA inspection.

Built on a proven QMS track record

We have implemented quality systems compliant with both ISO 13485:2016 and FDA 21 CFR Part 820, and know where they meet and where they differ.

Medical Devices and IVD focus

The QMSR applies to finished device manufacturers, including IVDs and software as a medical device. Our experts cover each category's regulatory nuance.

Gap to remediation in one engagement

We do not stop at the gap assessment. Our teams support the remediation of every finding, so your system holds up under inspection.

A bridge between your EU and US systems

Already compliant for Europe under MDR or IVDR? We help you build on that ISO 13485 foundation to meet the FDA's added expectations.

What we offer

End-to-end QMSR support, tailored to where you stand today and where you want to sell tomorrow:

QMSR Gap Assessment

We benchmark your existing quality system against the QMSR, including ISO 13485:2016 and the FDA's supplemental requirements, and deliver a clear, prioritized picture of where you stand.

QMSR Remediation & Implementation

We update procedures, close documentation gaps, and align labeling, packaging, and records controls with 820.45 and 820.35. For new entrants, we build a QMSR-compliant system from the ground up.

FDA Inspection Readiness

We prepare you for the new risk-based Compliance Program (CP 7382.850), making risk-based decision-making visible across supplier controls, design, software validation, and post-market activities.

QMS Internal Audits

Independent internal audits give you an objective view of your system's health and surface issues before an inspector does — full-scope or targeted.

MDSAP Readiness

We help you prepare for a single QMS audit that several regulators, including the FDA, may accept in place of routine surveillance inspections.

Regulatory Consultancy & Training

Tailored guidance and training on ISO 13485:2016 and the QMSR, so your team understands not just what changed but why it matters under FDA scrutiny.

Our process

From a focused gap assessment to a fully remediated, inspection-ready system, we follow a structured path that turns the QMSR transition into a chance to streamline how your quality system runs.

Gap assessment

We benchmark your QMS against ISO 13485:2016 and the FDA's supplemental QMSR requirements.

Remediation plan

We prioritize findings and design a pragmatic remediation roadmap aligned with your market goals.

Implementation

We update procedures, controls, and documentation, and integrate them into your daily operations.

Inspection readiness

We rehearse the FDA's risk-based inspection program (CP 7382.850) so your team is ready when inspectors arrive.

Why QbD Group

Your trusted partner

Your trusted partner for QMSR. More than a decade of expertise and a team of over 600 specialists, delivering end-to-end support that leaves your quality system robust, compliant, and ready for whatever comes next.

Dual-framework expertise

a proven track record across both ISO 13485:2016 and FDA 21 CFR Part 820, so the move to QMSR builds on what you already have.

Device and IVD specialists

deep, sector-specific knowledge of medical device, IVD, and software quality requirements.

EU-to-US bridge

we help manufacturers already compliant for Europe extend their ISO 13485 foundation to the FDA's requirements, rather than running two separate systems.

Customer-centric approach

we tailor every engagement to your starting point and your market goals, working as an extension of your team.