Regulatory Pathway for Licensed Planning
How licensed CT-based planning software moves from Research Use Only toward a cleared SaMD (CE/MDR, FDA, TITCK), and what the OEM and software partner each own.
Key takeaways
A licensed CT-based orthopedic planning platform does not have to be cleared on day one to be useful to a manufacturer. The realistic SaMD regulatory pathway for planning software runs in stages: start as Research Use Only (RUO) for a pilot, build the evidence and quality system, then pursue a cleared Software as a Medical Device classification under the relevant framework (CE/MDR in Europe, FDA in the United States, TITCK in Turkey). RUO is a legitimate, honest starting point, not a shortcut, because a pilot is how a vendor-neutral planner and a manufacturer learn whether the workflow is worth formalizing before either side spends on a submission. In that path the responsibilities split cleanly: the software partner owns the algorithm, the quality management system, the technical documentation, and the clearance for the planning function, while the manufacturer owns its implant, its own device clearances, and its clinical relationships. IP and who leads each regulatory step are defined by contract. Salnus builds implant-agnostic, vendor-neutral planning software for manufacturers to license and is currently RUO, not cleared, so every OEM engagement is a pilot or co-development, with no clearance, outcome, or superiority claim made today.
Why RUO is a legitimate starting point
Research Use Only is often misread as a weaker or provisional label. In practice it is the correct posture for software that is real, that is being validated, but that has not yet completed a clearance for clinical decision-making. RUO software can be used to plan, to measure, and to gather evidence in a research and pilot context, precisely the setting in which a manufacturer and a software partner should test a new workflow before committing to a regulatory submission.
For an OEM evaluating digital planning, this matters commercially. A pilot under RUO lets the manufacturer see the CT-to-3D planning workflow on its own implant library, with its own surgeons, on real anatomy, without either party pretending the tool is already a cleared device. That honesty is a feature. It sets expectations correctly, keeps claims defensible, and produces exactly the evidence a later submission needs. Skipping the pilot to rush a claim is the opposite of derisking.
The stages from RUO toward a cleared SaMD
The path is not a single event. It is a sequence, and each stage produces the inputs for the next.
Stage one: RUO pilot. The software is deployed for research and evaluation. The manufacturer and the software partner define what a good plan looks like on the OEM's catalog, capture reproducibility and workflow data, and decide whether the value justifies formalization. No clinical-decision claim is made.
Stage two: quality system and evidence. Before any clearance, the software needs a quality management system (commonly aligned to ISO 13485), risk management, and structured technical documentation. Evidence gathered in the pilot feeds analytical and, where required, clinical validation. This is unglamorous groundwork, and it is where most of the real cost and time sit.
Stage three: classification and submission. Planning software of this kind is treated as Software as a Medical Device. The exact class and route depend on the jurisdiction and the intended use, and the submission is prepared against the relevant framework. The intended-use statement, written carefully, is what fixes the classification, so it is drafted early rather than retrofitted.
Stage four: cleared use. Only after clearance in a given market does the software carry a clinical-use claim there, and only within its cleared intended use. Until then, the honest label stands.
None of this implies Salnus holds a clearance today. It does not. The value of laying out the stages is that a serious medtech decision-maker can see the full road and scope a pilot knowing where it leads.
CE/MDR, FDA, and TITCK are separate roads
A common planning mistake is to treat "getting cleared" as one destination. It is three, at least, and they do not automatically transfer.
CE/MDR (Europe). Under the Medical Device Regulation, software with a medical intended use is classified as a device, typically requiring a notified body for the relevant risk class, a technical file, and clinical evaluation. This is usually the reference framework for a platform aimed at European surgeons.
FDA (United States). The US route is its own regime, most often a premarket pathway appropriate to the device's risk and novelty. Predicate logic, intended use, and the software's role in the clinical decision shape which route applies.
TITCK (Turkey). Turkey's authority operates its own registration and oversight, broadly harmonized with the European direction but distinct in process. For a company based in Istanbul, this is a natural early market, but a Turkish path does not by itself grant European or US clearance.
The practical consequence for an OEM: a clearance in one market is not a global pass, and a licensing conversation should name which markets matter, because that drives which submissions the software partner leads and in what order. This is one of the concrete items worth raising when licensing implant-agnostic planning.
Who owns what on the regulatory path
The cleanest engagements separate ownership up front, and the split usually looks like this.
The software partner owns the planning function. The algorithm, the quality management system, the technical documentation, and the clearance for the planning software itself sit with the party that builds and maintains it. This is what keeps a vendor-neutral engine genuinely neutral across the manufacturers that license it: the core is not transferred every time an OEM co-funds an extension.
The manufacturer owns its device and its clinical relationships. The implant, its own regulatory clearances, its inventory and catalog, and its surgeon relationships stay with the OEM. The planning software supports correct sizing and use of that implant, but it does not absorb the manufacturer's device obligations, and the manufacturer does not inherit the planning software's clearance burden.
IP and regulatory lead are contract-defined. Who holds the marketing authorization, who is the legal manufacturer of the software, who funds which submission, and who owns co-developed extensions are all decided by agreement, not by who paid last. This is the same discipline that governs the commercial side of the relationship, and it maps directly onto the manufacturer-pays model and onto any white-label arrangement where the OEM's brand sits on the surface while the regulated engine stays with the software partner.
Getting this split written down early is what prevents a later dispute about who owns the clearance, and it is a large part of the build versus buy calculus for a manufacturer weighing in-house development against licensing.
Bottom line
The regulatory pathway for licensed planning software is a staged journey, not a switch: an honest RUO pilot first, then a quality system and evidence, then a SaMD submission under CE/MDR, FDA, or TITCK for the markets that matter, each of them a separate road. Along that path the software partner owns the planning algorithm, quality system, and clearance, while the manufacturer keeps its implant, its device clearances, and its clinical relationships, with IP and regulatory lead fixed by contract. Salnus is Research Use Only today and makes no clearance or outcome claim, which is exactly why an engagement starts as a pilot. If you are a manufacturer mapping how a licensed planner could reach a cleared status on your catalog, see how Salnus works with manufacturers to scope a pilot.
Reviewed by the Salnus biomedical engineering team.