QMSR inspection readiness for medical device cybersecurity
Cybersecurity is now a standard line item in QMSR inspections, and most quality teams haven't updated their audit prep for it. Medcrypt gives Quality a traceable evidence trail for every cybersecurity claim an inspector can ask about.
The readiness check is free and takes under an hour.
What QMSR inspections now check
Inspectors now review cybersecurity as part of your quality system, not only your submission.
Risk management leads the citations
Across the first 100 QMSR inspections, risk management has been the top citation area. Your security risk records need to tie back to your threat model.
SBOM and SPDF records are standard
Software bills of materials and Secure Product Development Framework documentation are now standard inspection elements, in the US and abroad.
Cyber devices meet Section 524B(b)(2)
For cyber devices, inspectors review your processes directly against Section 524B(b)(2) of the FD&C Act.
The postmarket duty never closes
Postmarket cybersecurity is a standing legal duty, not a one-time premarket gate. Your records have to keep up for as long as the device is on the market.
For Quality teams
Evidence your quality team can show FDA.
Every claim shows where it came from
Each cybersecurity claim carries a visible evidence trail. It is verified against a source, flagged as unverified, or marked as a documented judgment call, so you know what holds up before an inspector asks.
Mapped to the standards you already use
Evidence maps to ISO 13485, ISO 9001, IEC 62304 and TIR57, so cybersecurity fits into the quality system you already run instead of a separate binder.
Annual reassessment is a re-scan
When the device, its software or the guidance changes, Medcrypt re-scans against what changed. Your yearly review becomes an update, not a rebuild.
Built for inspection day.
Decision traceability
Every answer is labeled Verified, Unverified or Justified.
An inspectable audit trail
The full trail behind every generated answer stays open to review.
A mapped requirements library
Requirements map to IEC 62304 and FDA postmarket surveillance.
Former FDA reviewers on staff
Talk through your evidence with people who have sat on the other side.
QMSR · Section 524B
FDA retired its QSIT inspection approach on February 2, 2026, when the QMSR took effect and brought ISO 13485:2016 in by reference. Section 524B makes postmarket cybersecurity a duty you carry for as long as the device is on the market. For what inspectors now ask to see, read Naomi Schwartz's The New FDA Inspection Reality: Navigating the Shift from QSIT to QMSR & Section 524B.
Questions from quality teams
It's becoming a joint one. Cybersecurity is now a standard QMSR inspection line item your quality system has to demonstrate on its own. Medcrypt gives Quality the same evidence trail RA already relies on, without waiting on their timeline.
Thorough gets you most of the way there. What inspectors are trained to ask for now is traceability, exactly where each claim comes from, and that's the piece Medcrypt adds on top of the documentation you've already built.