Answers before you build.
Everything you need to know about Kubyk, from your first free prototype to a product in commercial use.
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Getting started
What is Kubyk?
Kubyk is the software foundation a digital health product runs on. If you're building a connected device or a health app, the device or app is only part of the job. You also need somewhere secure to send and store the data, a way for patients, clinicians and administrators to see it, user accounts and permissions, alerts when data stops coming in, and a way to update devices once they're in the field. Kubyk gives you all of that, already built and hosted, so your team builds only the part that's unique to your product.
You can start free while you're prototyping, run studies with real participants, and take your product to market, all on the same platform.
Who is Kubyk for?
Anyone building a digital health product, from a first prototype to a product in commercial use.
On Kubyk Pre-Commercial, that means students, labs and founders building and testing a product, and researchers and manufacturers running studies under IRB, ethics committee or FDA IDE oversight.
On Kubyk Commercial, it means medical device, digital health and pharma companies taking a product to market. Teams with their own quality function choose Standard, and teams that want to rely on our QMS and FDA Master File choose Enterprise.
Is it the same platform on every tier?
Yes. Every tier, from Lab to Enterprise Advanced, runs on the same platform and the same code base, so nothing you build along the way is throwaway code.
Is it really free to start?
Yes. Kubyk Lab is free for as long as you're building: no credit card, no trial clock and nothing to sign. We deactivate a Lab account only after 180 days without activity, and we tell you 30 days before.
What's included in the free tier?
Kubyk Lab gives you everything you need to build and share a working prototype: connect your devices and start collecting their data. It also includes KAI, our AI assistant, which answers your questions about the platform as you build, plus self-serve support. You can find Lab's limits on the Pre-Commercial page. See Lab's limits
Can I see a demo?
Yes. Start on Kubyk Lab for free and explore the platform yourself, with no booking and no credit card, or tell us about your product and we will walk you through it.
How is Kubyk different from building everything myself?
Building it yourself means creating and maintaining the infrastructure every digital health product needs before you get to the part that makes yours unique: device connectivity, secure data storage, a portal for each type of user, sign-in, firmware updates and audit logs. Kubyk already runs all of that, in production with regulated devices since 2020, so your team can put most of its time and budget into the product itself.
You also build on years of real-world experience instead of learning the same lessons from scratch, and on Kubyk Commercial, on a quality system and regulatory record that already hold up in review. Because every tier from Lab to Enterprise Advanced runs on the same platform and code base, nothing you build along the way has to be redone.
Kubyk Pre-Commercial
What's the difference between Kubyk Lab, Lab+, and Scale?
They are the self-serve Kubyk Pre-Commercial tiers. Lab is free, for a first prototype. Lab+ lets your team build and test a complete product, before any PHI. Scale runs your first study with real participants. Compare them
Can I use Lab for a course or a capstone?
Yes. Lab is free and takes simulated and non-clinical test data.
Can I switch between Lab and Lab+?
Yes. You can upgrade from Lab to Lab+ whenever your team needs a portal for each user type and higher limits, and your data and configuration carry over.
There's no downgrade from Lab+ to Lab, and Lab+ data can't be moved into a Lab environment. If you need Lab again, you can keep your Lab+ subscription and start a separate Lab environment alongside it, or end your Lab+ subscription and start a new Lab environment from scratch. Before you cancel, you can export your Lab+ data for your own records, though the export reflects Lab+'s fuller structure and can't be loaded into Lab as is.
Is there a trial?
Yes, Lab+ comes with a 30-day free trial option. Lab+ has nearly every feature of Scale and Kubyk Commercial, at lower limits and without PHI, so the trial lets you build and test a complete product. See pricing
Can I pay yearly?
Yes. Yearly billing on Lab+ and Scale gives you two months free. See pricing
Can I put real patient data on Lab or Lab+?
No. Lab and Lab+ take simulated data and non-clinical test data from your own devices, with no protected health information (PHI). Data with PHI runs on Scale.
When do I need Scale?
The day you need to hold protected health information: participant data in research under IRB, ethics committee or FDA IDE oversight, or in usability testing with your own staff or contractors, outside a care setting.
Does moving from Lab+ to Scale mean starting over?
No. Your Lab+ environment becomes your Scale Staging environment.
How do we sign the BAA?
Inside your account when you start Scale, with no contract to send back and forth.
What is outside these tiers?
Participants already in a care relationship, and any commercial use. They run on Kubyk Commercial.
Kubyk Commercial
What is Kubyk Commercial?
Products in commercial use, or with participants already in a care relationship, run on Kubyk Commercial: your own dedicated deployment under a custom agreement, operated under our QMS (ISO 13485 certified) and ISMS (ISO 27001 certified). Its tiers are Standard, Enterprise Basic and Enterprise Advanced. See Kubyk Commercial
Which tier fits our program?
Cleared or approved devices with live patient data run on Enterprise Advanced. Multi-site and pivotal studies, the data and system side of a regulatory submission, and commercial deployments with no clinical data run on Enterprise Basic. Standard fits teams that run commercial use under their own quality system.
What does "Enterprise" mean in a tier name?
We carry the regulatory work: we act as your critical vendor and carry nearly all of your solution's design history file. You stay the manufacturer.
What does Standard mean?
The standard product, run under your own quality system, with commercial use permitted.
Can we run it on our own infrastructure?
On Enterprise Basic and Enterprise Advanced, yes: in your cloud or on-prem, where specific infrastructure and regulatory verification requirements apply. Standard runs as a dedicated deployment in Azure, in our subscription or yours.
Is there a quality agreement?
Yes, on every tier. Standard uses one template for every customer, with our column covering the platform. On Enterprise Basic and Enterprise Advanced, the responsibility list sits mostly with us.
Can we reference the FDA Master File?
On Enterprise Basic and Enterprise Advanced, yes, directly in your regulatory submissions. Standard has no direct Master File reference.
How is Kubyk Commercial priced?
Monthly, under a custom agreement, from the starting prices published on Pricing. We confirm the price for yours when we scope your deployment. See pricing
Features and data
What kind of devices and data sources does Kubyk support?
Your own devices connect directly to the Kubyk cloud, or over Bluetooth through the Kubyk mobile app, with your own processing if you need it. Data from third-party devices comes in through their maker's cloud, with no custom coding, and data people keep in a health aggregator on their phone, like Apple HealthKit, comes in through the Kubyk mobile app. Third-party and aggregator sources are on every tier, and we keep adding new ones. See Features
Does Kubyk support single sign-on?
Yes, on Scale and Kubyk Commercial. Your team signs in to the System Admin Portal with your organization's accounts, and each of your customers' organizations can sign in to its Tenant Admin Portal through its own identity provider, with OpenID Connect or SAML 2.0.
Can we update device firmware over the air?
Yes, on Lab+, Scale and the Enterprise tiers. Send signed firmware to every device of one kind or to a single device, as a required or optional update, and see which version each device runs.
Is there an audit trail?
Yes, on Scale and Kubyk Commercial. Every change is recorded with who made it, when, and what it changed from and to, and a dedicated auditor role can review it.
Can I export my data?
Yes. Admins can export readings as CSV at any time, for analysis, reporting or migration.
Who owns my data?
You do. Kubyk makes no claim to your data. Everything you upload, collect or generate on the platform belongs to you. We store and process it on your behalf. For full details, see our Terms of Service and Privacy Policy.
Who owns my algorithm?
You do, along with its verification and validation.
What does KAI do?
It answers questions from the Kubyk documentation. It does not write or change your code.
Terms, certificates and hosting
What compliance certifications does Kubyk have?
Kubyk Commercial is operated under our QMS (ISO 13485 certified, recertified in 2026 and valid through 2029) and ISMS (ISO 27001 certified, valid through 2027). The Enterprise tiers can also reference our FDA Master File, referenced in multiple cleared 510(k) devices. Kubyk Lab, Lab+ and Scale are not operated under our QMS (ISO 13485 certified) or ISMS (ISO 27001 certified), and your product inherits no certification from them. The certificates and the Master File are held by KeborMed Inc., the company that builds and runs Kubyk.
Which terms apply to me?
On Lab, Lab+ and Scale: the Kubyk Master Terms, your tier's Schedule and the Privacy Policy, plus a BAA on Scale. On Kubyk Commercial: a Master Services Agreement and its related agreements, negotiated and signed for your deployment.
Is Kubyk FDA-cleared?
Kubyk is the infrastructure your product runs on, so the clearance belongs to your product. On the Enterprise tiers, your submission can cite our FDA Master File, already referenced in multiple cleared 510(k) devices.
Where is my data hosted?
Lab, Lab+ and Scale run on secure Azure infrastructure that we host and manage, so there is nothing for you to set up or run. Standard runs in a dedicated Azure deployment, in our subscription or yours, and the Enterprise tiers can also run in your cloud or on-prem.
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