Question 1

What is the QMSR?

Accepted Answer

The Quality Management System Regulation (QMSR) is the FDA's replacement for 21 CFR Part 820. It incorporates ISO 13485:2016 by reference, making the international standard the primary compliance framework for US medical device manufacturers. It became effective February 2, 2026.

Question 2

Is the QMSR effective now?

Accepted Answer

Yes. As of February 2, 2026, the QMSR is in effect. FDA inspections now reference ISO 13485:2016 with QMSR-specific additions. There is no grace period.

Question 3

Does the QMSR apply to my company?

Accepted Answer

If you manufacture, design, or distribute a medical device marketed in the United States, yes. This includes US-based manufacturers, foreign manufacturers exporting to the US, contract manufacturers, and specification developers.

Question 4

What's the difference between the QMSR and Part 820?

Accepted Answer

Part 820 was the FDA's own set of quality system requirements. The QMSR replaces it by incorporating ISO 13485:2016, the international standard. The core quality system elements are similar, but the structure and specific language changed. The FDA also added a small number of QMSR-specific requirements on top of ISO 13485.

Question 5

We're ISO 13485 certified. Are we QMSR compliant?

Accepted Answer

Certification is a strong starting point but doesn't guarantee QMSR compliance. The QMSR includes FDA-specific additions (complaint handling, servicing, traceability) that may not be covered by your ISO 13485 certificate. You should verify alignment with these additions specifically.

Question 6

Is legacy Part 820 terminology a compliance violation?

Accepted Answer

Not automatically. Using terms like "Device Master Record" instead of "medical device file" won't trigger a citation on its own. However, it signals to an FDA inspector that your system may not have been updated for the QMSR, which can invite closer scrutiny of your overall QMS.

Question 7

What's the difference between a gap analysis and an internal audit?

Accepted Answer

A gap analysis asks: does our system cover what the standard requires? An internal audit asks: do we follow our own procedures? A gap analysis is about coverage; an audit is about conformance. You typically need both.

Question 8

What does "audit-ready" mean?

Accepted Answer

It means your QMS is organized, documented, and maintained well enough that you could receive an FDA inspection or ISO audit without scrambling to prepare. Your documents are current, your records are complete, and you can demonstrate that your system functions as described. It does not mean you will pass — it means you are prepared to be evaluated.

Question 9

What does the QMSR scanner check?

Accepted Answer

The scanner evaluates your QMS documents against 37 ISO 13485 clauses with QMSR overlay. For each clause, it assesses whether your documents address the requirement, how thoroughly, and flags gaps, incomplete coverage, and legacy terminology.

Question 10

Do you store my documents?

Accepted Answer

No. We request read-only access to your Google Drive. Your documents are analyzed in-flight — the content is processed through our analysis and only compliance metadata (gap findings, clause references, document classifications) is retained. We never store your document text.

Question 11

How accurate is the scan?

Accepted Answer

The scanner identifies structural gaps — missing procedures, incomplete coverage, legacy terminology — with high reliability. It's a screening tool, not a completed gap assessment. Think of it as a very thorough first pass — the starting point for expert review, not a replacement for it.

Question 12

How long does a scan take?

Accepted Answer

Most scans complete in under 10 minutes, depending on the number of documents in your Drive. You'll get results as a prioritized gap report that you can review, export, and share with your team.

Question 13

Is the free scan really free?

Accepted Answer

Yes. The free scan gives you a full review with personalized findings, domain scores, and a gap list with clause references — genuinely useful, not a teaser. The paid report adds exportable PDF, per-document detail, and remediation guidance.

Question 14

Can the scanner handle SharePoint or OneDrive?

Accepted Answer

Not yet. Google Drive is supported first. SharePoint and OneDrive support are on our roadmap.

Question 15

Why "Kelsey"?

Accepted Answer

Kelsey Quality is named for Frances Oldham Kelsey, the FDA reviewer who kept thalidomide out of the US market in the early 1960s by refusing to approve an application without sufficient evidence. Her thoroughness, determination, and principled judgment saved thousands of lives and led to stronger drug safety regulations. She represents what we believe quality work should be — and what we built this tool to support.

Common Questions About QMSR Compliance

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