Since 2010, Monterail has worked with founders at every stage, from first brief to mid-build rescue. We know what keeps products off the market, and build around those risks from sprint one.
Trusted by healthcare leaders
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Recognized by Financial Times FT1000 and Deloitte Technology Fast 50.
DELIVERED AND CLEARED
Funding raised
20+ industry awards
Consumer Device · FemTech · IoT
FDA-cleared device generations
5+ year partnership
Medical Device · FDA Class II · IoT
Chronic pain relief wearable
Clinical-grade neurostimulation
Wearable · CE-marked · FDA BDD
Fortune 500 · Digital Platform · Enterprise
Fortune 500 · Digital Platform · Enterprise
YOUR HEALTHTECH EXPERT
Collaboration with Monterail was wonderful because they got the job done to create the product, but also, they know how to reach out to the end-user through the product. Together, we empowered mothers to feel safe and comfortable doing one of the most natural things for humankind.
Tania Boler — Founder, Elvie
Collaboration with Monterail was wonderful because they got the job done to create the product, but also, they know how to reach out to the end-user through the product. Together, we empowered mothers to feel safe and comfortable doing one of the most natural things for humankind.
Tania Boler Founder, Elvie
I was impressed by Monterail's services. Not only did they bring their technical expertise to the table, but they showed their sensitivity to the particular cultural context of this project by asking a lot of meaningful questions early on.
Alexander Hoffman — Head of Digitization Africa, Merck
I was impressed by Monterail's services. Not only did they bring their technical expertise to the table, but they showed their sensitivity to the particular cultural context of this project by asking a lot of meaningful questions early on.
Alexander Hoffman Head of Digitization Africa, Merck
I am really glad that Monterail's reliable team has helped us to squeeze our product to the fullest. An experienced software and product team is crucial to comply with medical regulations.
Michael Foester — Co-Founder & CTO, Remedee Labs
I am really glad that Monterail's reliable team has helped us to squeeze our product to the fullest. An experienced software and product team is crucial to comply with medical regulations.
Michael Foester Co-Founder & CTO, Remedee Labs
What impressed me the most about the team is how quickly they grasped what we are trying to achieve, and how they supported us to bring our vision to life. We have a world-class product and we wouldn't have gotten to this point alone. Monterail was the perfect partner to get us here.
Alon Lits — Co-Founder, October Health
What impressed me the most about the team is how quickly they grasped what we are trying to achieve, and how they supported us to bring our vision to life. We have a world-class product and we wouldn't have gotten to this point alone. Monterail was the perfect partner to get us here.
Alon Lits Co-Founder, October Health
Key healthcare product challenge
Most healthcare founders defer the hard decisions and face them again at later stages. Either mid-submission, during due diligence, or under audit, when changing course costs the most.
Where you are now determines what you need next.
“In 15 years, I've seen more rebuilds than I'd like to count. It always costs more than the original build, both in time and money. And almost every time, it was avoidable.”
Piotr Zając — HealthTech Director, Monterail
“In 15 years, I've seen more rebuilds than I'd like to count. It always costs more than the original build, both in time and money. And almost every time, it was avoidable.”
Piotr Zając HealthTech Director, Monterail
Where are you in your healthcare product journey?
Whether you're building a SaMD or a companion app, where you land on that line shapes every technical decision that follows. We help you figure that out early so you can build with clarity from the start.
Technical debt before regulatory submission is the most expensive kind. Having worked with teams already deep in development, we know how to fix what's not working so you can get to submission without starting over.
Whether you are scoping a product or already deep in development, Monterail's health team has seen it before. 30 minutes to figure out where you stand.
Book a product reviewHealthcare software development process
Many of our partnerships run for years, some for over a decade. From the first product decision to long-term maintenance, Monterail supports you at every step, whether you come with just a brief or with development already underway.
Define business goals, user needs, regulatory path.
UI/UX, user flows, interactive prototypes.
Build core features, hardware integration, APIs.
QA, clinical validation support, staging.
Live release, monitoring, go-to-market support.
Long-term evolution, updates, compliance upkeep.
Trusted by industry leaders
Our focus
An idea gets you started but evidence gets you funded, cleared, and to market. Monterail's discovery process results in a validated product brief covering regulatory path, architecture, and UX prototype, so you invest in the right product from day one.
Whether you're starting fresh or already deep in development, we meet you where you are. We integrate compliance activities throughout the development lifecycle to ensure that your healthcare application passes regulatory review the first time, saving you costly revisions and launch delays.
A health device is only as good as the systems behind it. Since 2012, we've shipped integrations across BLE, Wi-Fi, sensor fusion, IMU, Apple Watch, iOS/Android, and IoT infrastructure. Your device will work the way clinicians and patients need it to, and holds up under regulatory scrutiny.
Regulatory standards we follow
The path to FDA clearance or CE marking is determined by decisions made at the very beginning. It's our standard that regulatory documentation is written as development happens, so nothing needs to be reconstructed before submission.
Every product includes design controls, a traceability matrix, IEC 62304-compliant lifecycle records, and audit-ready data architecture. Your regulatory team gets what they need to submit, right on time.
EU AI Act high-risk obligations take effect in August 2026. We've built a team dedicated to regulated health AI competencies around audit trails, explainability documentation, and compliant model governance, so the deadline doesn't become a blocker for your product.
We've also been on both sides of due diligence, as founders and as people who've evaluated health products from an investor's perspective. That changes the decisions we push on in the first sprint and which architectural shortcuts we refuse to take.
Standards we build to
EU-rooted engineering team
Monterail is based in Poland, and our clients operate in the United States, Europe, the Middle East, and Africa. The products we have built with them received FDA clearances, CE marks, and Breakthrough Device Designation.
EU MDR set a stricter engineering bar than FDA SaMD. It means more rigorous post-market surveillance and deeper software lifecycle requirements. Products built to that standard tend to clear the US market as well.
Regulatory affairs
Clinical testing
Hardware & IoT
Legal & IP
Investor relations
Market access
Looking for support in those areas? We'll connect you with experts from our trusted partner network so you're never navigating the hard parts alone.
Get our supportEnterprise healthcare rapid prototyping
83% of companies rank innovation as a top-three priority. Only 3% describe themselves as innovation-ready. Most of those briefs never become anything.
The gap is in procurement cycles and six-month discovery phases. We move faster than that by operating as a health innovation lab. One defined use case, four weeks, and a working prototype your decision-makers can base a go/no-go call on.
Technical support and development for connected, app, and high-tech concepts is particularly valuable for us. Monterail got the job done well, the brief was met, and the prototypes work.
Nick Sardar — Senior Manager, SharkNinja
Technical support and development for connected, app, and high-tech concepts is particularly valuable for us. Monterail got the job done well, the brief was met, and the prototypes work.
Nick Sardar Senior Manager, SharkNinja
Let's Talk.
Schedule a 30-minute call to discuss your healthcare product needs. Share your name, work email, and one line about what you’re up to.
