Is VirtuCath validated?
VirtuCath's physics is checked: the stiffness model is validated against bench data, and the kink, push and steering simulations are verified against exact solutions and published references. What no software vendor can do is validate VirtuCath for your use. Under the FDA's Quality Management System Regulation (QMSR) and ISO 13485, that step belongs to the device manufacturer and is scaled to the risk of how the tool is used. Used as intended, as an R&D design aid whose results are confirmed by physical testing, that risk is low.
VirtuCath is not validated for, and not intended for, use as design verification evidence or in a regulatory submission. That is a deliberate choice: every result is confirmed by physical testing, which is why the risk of using it is low.
"Validated" means three different things
| The question behind "is it validated?" | Answer |
|---|---|
| Does the model predict real catheters? | Yes, within stated limits. The stiffness model is validated against published and in-house bench data; the Kink Radius, Pushability and Steering simulations are verified against exact solutions and published references. The reports are listed below; errors and limits are on Model accuracy. |
| Is it validated for use in our quality system? | No. That decision, and any validation it calls for, belongs to the manufacturer using the software, for its own use; the regulation assigns it there. VirtuCath, LLC does not offer validation packages or validation services. |
| Can its results be used as design verification evidence or in a submission? | No. VirtuCath is a design aid for research and development; its results are not a substitute for physical testing (EULA section 10.4). |
What the QMSR requires
Since February 2, 2026, the FDA's device quality regulation (21 CFR Part 820, the QMSR) requires a quality management system that complies with the applicable requirements of ISO 13485:2016, which it incorporates by reference (§ 820.10(a), § 820.7). For software used in the quality system, the applicable requirement is ISO 13485 clause 4.1.6, which asks the manufacturer to:
- validate the application of computer software used in the quality management system;
- do so before first use and, as appropriate, after changes to the software or to how it is used;
- make the approach and activities proportionate to the risk associated with the use of the software;
- keep records of it.
Three things follow:
- Validation is of your use, not of the product in general. The same software can be low risk in one company's process and high risk in another's, so the validation cannot be bought from the vendor. A vendor's evidence can be referenced in it.
- The effort scales with risk. The former regulation (§ 820.70(i)) asked for software to be "validated for its intended use according to an established protocol". Clause 4.1.6 asks for validation in proportion to the risk of the use. The FDA's guidance on Computer Software Assurance (2025) takes the same risk-based approach for software used in production and the quality system.
- "Risk" means risk to the device. The QMSR does not define risk for itself. FDA kept ISO 13485's meaning (clause 0.2): risk "pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements".
The same clause applies wherever ISO 13485 is the quality system standard, in or outside the United States.
Why the risk is low when VirtuCath is used as intended
Ask what happens to the device if a VirtuCath result is wrong.
- The effect: a design candidate, or a prototype built to it, performs differently from the prediction.
- Where that is caught: design verification and design validation (ISO 13485 clauses 7.3.6 and 7.3.7) are required for every device and are done by physical testing of the device itself. A wrong prediction cannot reach a finished device without passing through them.
- What it costs: time and prototypes. A wrong prediction does not change the finished device's safety or performance, or whether it meets its regulatory requirements, which is the risk the QMSR asks about.
The fabrication numbers from the Reflow Calculator and the Braid Transfer Calculator are covered the same way: they are for building prototypes, and each size or braid value is confirmed by measuring built parts before it is used on a drawing, in a purchase specification or in a production process.
When the risk is not low
The reasoning above holds only while VirtuCath results are confirmed by physical testing. Treat the use as higher risk, and expect a fuller validation, if your team uses a result to:
- serve as design verification evidence, or to remove or reduce a physical test;
- choose which configuration is the worst case to test;
- set a specification or an acceptance criterion without confirming it on the bench;
- support a regulatory submission (credibility of a computational model is then assessed separately, for example under ASME V&V 40).
Evidence you can reference
Cite each report by its document ID and version. A new version of a report gets a new version number; an ID is never reused.
| Document | ID, version | What it shows | Download |
|---|---|---|---|
| Validation of the VirtuCath Stiffness Model | VR-VC-003, 2.1 | Bending, torsional and axial stiffness (EI, GJ, EA) against published and in-house bench data, and a sealed test of the calculator on 400 designs it never saw | |
| Verification of the VirtuCath Kink Radius Simulation | VR-VC-004, 1.4 | The kink and collapse solver against exact beam and thin-shell solutions, with a refinement study | |
| Verification of the VirtuCath Pushability Simulation | VR-VC-005, 1.2 | The push and buckling solver against Euler's exact elastica, with refinement, contact and friction checks | |
| Verification of the VirtuCath Steering Simulation | VR-VC-001, 5.0 | The steering solver against exact beam theory and a published Cosserat-rod reference on 949 catheters |
Results, error figures and limits for each are summarized on Model accuracy.
Other published information:
- Installer integrity: SHA-256 of every release installer, in section 5 of the IT security and compliance page, and how to check the code signature, in Code signing.
- Security, data handling and the software bill of materials: the IT security and compliance page and the IT deployment guide.
- Terms of use: the EULA, section 10.4 for the intended use.
Frequently asked questions
Is VirtuCath, LLC certified to ISO 13485?
No. VirtuCath, LLC is not certified to ISO 13485 and does not yet operate a quality management system.
ISO 13485 clause 7.4 scales supplier controls to the effect of the purchased product on the quality of the medical device; how to evaluate VirtuCath as a supplier is your quality team's decision. What VirtuCath, LLC publishes:
- the verification and validation reports above, each with a document ID and a document history;
- the full automated test suite, which every release build runs, or confirms was run on the identical code, before the release is built (from 1.7.4);
- signed installers, with the SHA-256 of each published on the IT page;
- a software bill of materials shipped with the installer.
Can we use VirtuCath to choose the worst-case configuration to test?
You can, but it is no longer the low-risk use: a wrong ranking would mean testing the wrong configuration. Either justify the worst case on engineering grounds and use VirtuCath only in support, or treat the use as higher risk and confirm the ranking on the bench first.
What about materials we add to the library?
Material data you enter is an input you control, like any other design input: record where it came from.
Does FDA need anything from VirtuCath, LLC?
Your determination and the evidence it cites are what an investigator would review, and both live in your records. If a supplier file or an audit needs something from us, ask (below).
Questions
For questions about this page, a supplier qualification or an audit, email [email protected] with the
subject line beginning [Quality].
References
- Medical Devices; Quality System Regulation Amendments, final rule, 89 FR 7496 (February 2, 2024), effective February 2, 2026: § 820.7, § 820.10, and the preamble's responses on the meaning of risk and on records access.
- ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes: clauses 0.2, 4.1.6, 7.3.6 and 7.3.7.
- FDA, Computer Software Assurance for Production and Quality System Software, guidance (September 2025).
This page explains how VirtuCath is designed to be used and the regulation that applies to it. It is not regulatory advice. Whether and how to validate VirtuCath is your quality team's determination, for your process.