Investment & Engagement Model
Medical device software is bespoke, so we scope before we quote. Here's how we structure engagements, what drives cost, and how to get a proposal for your project.
Request a QuoteWe scope first, then quote
Every engagement begins with understanding your device, its regulatory classification, and what a successful outcome looks like. From there we provide a detailed, defined-scope proposal — most often a fixed-bid quote, with time-and-materials available for embedded-team and ongoing-partnership work. We don't publish a rate card because a single number can't reflect the range of regulatory and technical requirements across medical device projects.
What affects the cost of medical device software
These are the factors we work through during scoping to produce an accurate quote.
Regulatory classification
A Class I wellness accessory and a Class III implant-adjacent system carry very different documentation, V&V, and risk burdens.
IEC 62304 software safety class
Class A, B, or C determines how much architecture, detailed design, and unit-level verification the lifecycle requires.
Verification & validation scope
Test protocol development, traceability, and the Design History File needed for an FDA submission scale with risk.
Connectivity & platforms
BLE, WiFi, Serial, custom protocols, and the number of target platforms (iOS, Android, Windows, embedded) all add scope.
Integrations & data
Cloud sync, EHR/HL7/FHIR, DICOM, and AI/ML features introduce additional design, security, and validation work.
Timeline & team model
A fixed-scope project, an embedded engineer, or a multi-year partnership are scoped and quoted differently.
How we engage
We match the engagement model to your program — not the other way around.
Fixed-bid project
Defined scope, defined deliverables, a single quoted price. Scoped after a discovery phase so the number reflects the real regulatory and technical requirements — not a guess.
Embedded team / staff augmentation
One or more of our engineers integrate directly with your team. Used by clients who need specialized device-software expertise inside an existing program.
Discovery & audit
A focused engagement — architecture audit, IEC 62304 gap assessment, or V&V readiness review — that de-risks scope before a larger build.
Pricing & Engagement: FAQ
How is medical device software development priced?
Most engagements are fixed-bid: we run a discovery phase to understand the regulatory classification, technical scope, and validation requirements, then quote a defined scope of work. Some engagements run as time-and-materials, especially embedded-team and ongoing-partnership work.
Why don’t you publish prices or a rate card?
Medical device software is bespoke — the same feature can carry very different cost depending on regulatory class, IEC 62304 safety classification, and V&V scope. A published rate card would be misleading. We scope first, then quote a number that reflects your actual requirements.
What does a quote depend on?
The main drivers are regulatory classification, IEC 62304 software safety class, the verification & validation and documentation burden, the platforms and connectivity involved, integrations and AI/ML, and the engagement timeline and team model.
Do you offer fixed-bid or time-and-materials?
Both. Defined-scope builds are typically fixed-bid; embedded-team and longer partnerships are typically time-and-materials. We’ll recommend the model that fits your program during the initial conversation.
How do we get a quote?
Tell us about your device and goals. We start with a consultation, then a discovery phase if needed, and provide a detailed proposal with a defined scope and price.
Ready for a proposal?
Tell us about your device and goals. We'll scope the work and provide a detailed quote.
Request a Quote