Common questions about medical device compliance

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.

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.

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.

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.

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.

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.

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.

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.

A full evaluation checks your QMS documents against 195 requirements across 8 regulatory standards (QMSR / ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 81001-5-1, FDA Cybersecurity, FDA Postmarket Surveillance, and IVD Products (21 CFR 809)) — assessing whether each requirement is addressed, how thoroughly, and flagging gaps, incomplete coverage, and legacy terminology. The free scan runs the structural layer of that same knowledge base: document coverage, missing document types, and terminology gaps, without a per-requirement verdict.

We never store or copy your full documents. We request read-only access to your Google Drive, and your documents are analyzed in-flight. We retain compliance metadata — gap findings, clause references, document classifications — and, as evidence behind each finding, short quoted excerpts from your documents. Full document content is never written to persistent storage. See our privacy policy for details on excerpt retention.

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 thorough automated scan — the starting point for expert review, not a replacement for it.

It depends on the scan. A structural scan across your Drive returns in seconds. A deep conformance evaluation of a single document typically takes under two minutes — the first point where you wait on the AI evaluation. A full clause-by-clause evaluation of an entire quality system runs longer, typically 15–60 minutes depending on how many documents you have and how dense they are.

Yes. The free scan runs a full structural pass across your Drive — document coverage, missing document types, superseded language, and terminology gaps — genuinely useful on its own, not a teaser. The paid gap analysis adds clause-by-clause requirement evaluation and remediation guidance across every document. The free scan isn't live yet — join the waitlist and we'll email you when it opens.

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

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.