ISO 13485 Software
ISO 13485 Software
For the QMSR Era.
QMS software for medical device manufacturers, built by ISO consultants, for the year ISO 13485 became FDA's quality system regulation.
The QMSR and the Risk File
FDA Starts With Your Risk File. Can You Back It Up?
The Quality Management System Regulation took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference, and FDA stopped inspecting with QSIT, moving to the process in Compliance Program 7382.850.
The early results are clear about where inspections are landing. At MedCon 2026, as reported by RAPS, FDA officials said that between February 2 and March 31 the agency issued the most 483 observations in risk management, followed by outsourcing and purchasing. One FDA official said companies are not adequately documenting their risk control measures: they are vague, or missing.
A risk control on paper is a claim. The proof is everywhere else in the quality system: the procedure that was revised, the people trained on the revision, the equipment that verifies it kept in calibration, the supplier controls behind a purchased component. Those are QMS records, and they are what My ISO QMS keeps controlled, current and retrievable, so when an investigator picks a risk control from your file, the evidence that it exists is a search away, not an afternoon in a shared drive.
Your ISO 14971 risk management file stays where your engineering team keeps it. FDA did not incorporate ISO 14971 by reference, but if your procedures cite it, expect to be held to it.
ISO 13485:2016, Clause by Clause
The Quality System Records, Mapped to Modules.
The system is built on the ISO 9001 process structure that ISO 13485 shares, and the records an investigator or notified body asks for live in these modules.
Automated test runs with visual evidence of each test passing, assembled per release, covering the operational qualification side of validating the QMS software itself.
Current revisions, approval records and status for every controlled document, with superseded versions withdrawn instead of left on a shared drive.
Documented reviews with a snapshot of the quality system captured for each cycle, so the required inputs and outputs are on the record.
Training tied to requirements, completions signed off by the people trained, and a skills matrix that shows competence with evidence.
Supplier approval status, certificate expiry tracking and risk assessment, a live control for one of the areas FDA has cited most under the QMSR.
Calibration logs with due dates and expiration alerts, so nothing used to accept product is out of calibration.
A planned audit programme with findings raised, tracked and closed, rather than an audit schedule reconstructed before the inspection.
Sequential NCRs with recorded dispositions, each convertible into a corrective action with root cause and an effectiveness review.
ISO 13485 Software, Straight Answers
Before the Investigator Arrives.
Does My ISO QMS support the FDA QMSR?
The QMSR, effective February 2, 2026, incorporates ISO 13485:2016 by reference, so the quality system records it expects are the ISO 13485 ones: documents and records, training, suppliers, calibration, nonconforming product, CAPA, internal audit and management review. My ISO QMS runs those processes. Compliance itself is yours to demonstrate, and no software makes a manufacturer QMSR-compliant on its own.
Do you provide software validation?
Yes. ISO 13485 clause 4.1.6 expects you to validate software used in your quality system. We provide assisted software validation packages: automated test suites run against the system, with visual evidence of each test passing, assembled per release and available for your current version on request. That covers the operational qualification side; confirming the system fits your intended use stays with you, and we help with it.
Does it replace our risk management file?
No. Your ISO 14971 risk management file and design history stay where your engineering team keeps them. What the QMS does is hold the records that show risk controls were put in place: the revised procedure, the training on it, the calibrated equipment that checks it, and the supplier controls behind it.
Can it run on-premise?
Yes. On-prem runs inside your own network for $600/month with no seat limit, and the Air-Gapped Appliance covers sites where quality records must never touch the internet. Details are in the FAQ.
More in the full FAQ, or ask a consultant directly. A person answers, not a chatbot.
Show Us Your Risk Controls.
Pick three controls from your risk file and we'll show you where the evidence for each would live in the system, on your processes, not canned demo data.
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