Medical device software development
to the standard.
Medical device software runs under rules normal app development ignores. IEC 62304 lifecycle, risk management, traceability a reviewer will actually audit. We build that software to the standard from the first commit: SaMD, companion apps, and the data layer behind them. We engineer it. Your regulatory lead owns the FDA path, and we hand them what it needs. Built for medtech teams and device makers.
Scoped estimate in 3 to 5 days. No obligation, NDA on request.
“They were absolutely phenomenal. The team put in a lot of work to break down what was required of the project and gave an excellent presentation on the process. I highly recommend them and will be working with them again in the future.”
Kayode Leonard
Founder, Project Wolf
Selected clients and shipped projects
Awesome Kyiv
Shelfit
Who you work with
We engineer to the standard, and we have shipped under real scrutiny
HighCraft is a senior team that pairs full-stack engineering with applied AI for healthcare, SaaS, and expert-led businesses. We have earned Top Rated and a 100 percent Job Success Score on Upwork, one five-star delivery at a time.
Our proof is the discipline, not a borrowed badge. We shipped a HIPAA-aligned EMR and patient portal under real regulatory scrutiny, on a normal sprint cadence. We build systems-grade software for ourselves too. WebReaper, our open-source .NET scraper, ships as a Native AOT single binary across six platforms. That is the rigor medical-device software needs, from the people who would write yours.
2 weeks
idea to working prototype
End to end
prototype to production
Senior
engineers, no handoffs
The honest line first. We are a software engineering partner, not your regulatory consultant. We build to the IEC 62304 lifecycle and the documentation the FDA's Software as a Medical Device guidance expects. That means the risk files, traceability, and verification records an audit asks for. We work alongside your regulatory lead, not in place of them. If you need a turnkey FDA submission, that is a different partner, and we will point you to one.
What the work actually involves
What medical device software has to get right
The discipline a consumer app skips and a regulated device cannot.
IEC 62304 lifecycle, for real
Software safety classification, a documented lifecycle, and the SOUP handling a reviewer asks about. Built in from the first commit, not reconstructed the week before an audit. The class drives the rigor, and we set it with you up front.
Risk and traceability
Hazard analysis tied to requirements tied to tests. Every risk traces to a control, every control to a verification. The traceability matrix is the artifact a submission lives or dies on. We keep it current as we build, not retrofitted after.
SaMD, companion apps, and the data layer
Software as a medical device, the app that pairs with hardware over Bluetooth, and the cloud behind both. We engineer the parts that read, store, and move clinical and device data. All of it held to the same standard.
Verification, validation, the audit trail
Documented V and V, design history, and the records a reviewer or notified body will request. We produce them as we develop. The evidence exists when the submission needs it, not in a scramble once the timeline is tight.
Where we stop, and who picks it up
We are the software engineering team, not the regulatory consultancy. We build to IEC 62304 and produce the V and V and traceability records. We hand your regulatory lead exactly what a 510(k) or CE submission requires. We do not run the submission. We do not hold ISO 13485 or FDA clearance as an organization. We say that plainly rather than imply a credential we have not earned. When that is what you need, we point you to a regulatory partner and work next to them.
100%
Job Success on Upwork
5.0
Average client rating
Top Rated
Agency on Upwork
11 yrs
Engineering leadership
HIPAA
Aligned delivery
Recognition
Awards and accreditations
Verified on Upwork and recognized by independent agency directories.
Built for the rules healthcare runs on. Practices documented, not implied.
Security & trustAI Prototype Sprint
Validate the workflow before you fund the platform.
A two-week sprint that turns a complex workflow into a working prototype, architecture direction, and a build estimate you can act on.
- Working prototype
- Workflow map
- Architecture recommendation
- AI opportunity and risk assessment
- Delivery roadmap
- Fixed or phased build estimate
Two weeks, one fixed scope. You own everything we build, whether or not you continue.
Week 1
Discover the workflow, build the spine
Week 2
AI where it pays back, then prototype + estimate
Engagement models
Four ways to engage, and a low-risk way to start
We fit the model to the project and the risk, not to our invoice. Most clients start with a two-week discovery sprint that turns the idea into a working prototype and a real estimate, then move into whichever model fits the build.
Time and materials
You pay for the hours you use, billed weekly or monthly. The right call when scope is still moving and you want to steer as you go.
Dedicated team
A senior team embedded with yours and billed monthly, scaling up or down as the roadmap changes. Built for ongoing work, not a one-off.
Fixed price
Agreed scope, agreed price, agreed date. Works when the requirements are already clear and you want certainty before you sign.
Fixed milestones
Phased delivery, paid one milestone at a time. A way to take on a larger build and de-risk it stage by stage.
What clients say
Clients trust us with messy, real-world software
From regulated healthcare workflows to payment-heavy platforms and internal business systems, the common thread is delivery that survives production.
Alex and his team built the core of our Healthcare SaaS. Their grasp of HIPAA and GDPR was crucial for our telemedicine features, and they added AI into the EMR so providers could make better data-driven calls. They know the Microsoft stack and held to WCAG 2.1 throughout. For a healthcare product that needs regulatory care and real engineering, HighCraft.io is the partner you want.
Oleg Shumar
Owner, GetTrusted.io
They were absolutely phenomenal. The team put in a lot of work to break down what was required of the project and gave an excellent presentation on the process. I highly recommend them and will be working with them again in the future.
Kayode Leonard
Founder, Project Wolf
Really enjoyed working with HighCraft.io. They are true professionals that know how to get things done. They were hardworking and skillful, exactly what we were looking for.
Maxim Grossman
Executive, Enigmex Technologies
HighCraft team did a great job creating a brand new site for my company, and I am loving it. It is exactly what I wanted and the team were true professionals and very nice to work with.
Alina Virstiuk
Founder, AwesomeKyiv
What we do
Three ways we turn complex workflows into working software
Start with a prototype, add AI where it creates leverage, or build the full production platform.
Working prototypes
A working prototype built around the real edge cases, so you can validate scope before funding a full build. The cheapest way to find the edge case nobody mentioned.
AI-enabled features
AI inside the product you already run: intake, search, summarization, classification, recommendations, or workflow assistance, with evaluation and guardrails. Built so a real user opens it twice.
Production platforms
Custom platforms built for real users: integrations, permissions, billing, audit trails, and maintenance. HIPAA-aware where it has to be.
Free vendor-risk check
Before you build, check the risk first.
Answer a few plain-English questions and get a vendor-risk read on ownership, proof of work, data exposure, and handover gaps before you fund the build.
- Takes about 3 minutes
- No patient data
- Built for vendor decisions
The page shows the first risk instantly. Email sends the full report.
Related services
Part of the same healthcare build
If your project touches more than one of these, one team covers them.
Selected work
Software that works, in production
Our clients get to focus on their business, instead of babysitting the stack that holds it together. Client cases below are anonymized where compliance demands; the rest ship under their own names.
How we build
How we build AI workflows that stay controllable
Agentic does not have to mean opaque. We put the controls where the risk is: permissions, approvals, and audit around every AI-assisted step.
Frontend
The product your users and staff actually work in.
API
Typed contracts and validation at the boundary.
Workflow engine
The deterministic spine: states, rules, and handoffs.
Agentic workflow layer
Inspects context, suggests next steps, and triggers tools, with human approval where it matters.
AI / LLM services
Models behind evaluation and fallback logic, not raw and unchecked output.
Integrations
EMR, Stripe, CRM, scheduling, and internal APIs.
Audit, monitoring, permissions
Every AI-assisted step logged, observable, and role-gated.
Controls, not black boxes
- Human approval for sensitive actions
- Tool calls scoped by permissions
- Audit logs for every AI-assisted step
- Evaluation and fallback logic, not raw model output
- Role-based access throughout
- Observability in production
- Integration with EMR, Stripe, CRM, scheduling, or internal APIs
FAQ
Hiring a medical device software development team
What buyers ask before they start.
What is medical device software development?
It is building software that is part of a medical device, or is the device itself (software as a medical device). It runs under a regulated lifecycle: IEC 62304 development, risk management, and the documentation a submission requires. Both the engineering bar and the paperwork bar sit higher than ordinary software.
Do you handle FDA clearance or 510(k) submissions?
No, and we will not pretend to. We are the software engineering partner. We build to IEC 62304 and produce the verification, validation, and traceability records, then hand your regulatory lead what the submission needs. The 510(k) or CE filing runs through your regulatory team or a dedicated partner, and we work alongside them.
Can you build software as a medical device (SaMD)?
Yes. SaMD, the companion app that pairs with a device, and the cloud and data layer behind both. We classify the software and build to the matching IEC 62304 rigor. We keep the risk and traceability files current as we go, not reconstructed later.
How much does medical device software development cost?
Send the device, its intended use, and the safety classification you expect. We reply with a scoped estimate, usually within 3 to 5 business days. Cost tracks the safety class, the documentation depth, and the integrations. A Class C build carries far more verification than a Class A one.
Do you do embedded firmware on the device itself?
We focus on the software around and on top of the device: SaMD, the application layer, connectivity, and the cloud and data systems. For low-level firmware on the silicon we partner with a firmware specialist. We are clear about that line before the build, not after.
How do you keep the software auditable?
We build the traceability matrix, risk files, and V and V records as we develop, not as a retrofit. Requirements link to risks link to tests. When a reviewer asks why a control exists, the answer is already documented. Retrofitted traceability is where most timelines quietly slip.
When are you not the right fit?
If you need a regulatory consultancy to own your FDA strategy, or a firmware house for silicon-level work, we are not that. We will point you to one. We are the right call when you need medical-device software engineered to the standard, by a senior team that will not cut the documentation corner.
Start a project
Tell us about your project
Send the shape of the problem, even if the requirements are still blurry. We reply with a scoped estimate, usually within 3 to 5 business days. No obligation, NDA on request.
- A senior engineer reads every brief, not a sales rep.
- If an off-the-shelf tool fits better, we will tell you.
- NDA on request before you share anything sensitive.
Prefer email? Write to business@highcraft.io
Rather talk it through? Book a 30-minute estimate review
“Alex and his team built the core of our Healthcare SaaS. Their grasp of HIPAA and GDPR was crucial for our telemedicine features, and they added AI into the EMR so providers could make better data-driven calls. They know the Microsoft stack and held to WCAG 2.1 throughout. For a healthcare product that needs regulatory care and real engineering, HighCraft.io is the partner you want.”
Oleg Shumar
Owner, GetTrusted.io