SCOPE, REQUIREMENTS& MVP IN 10 DAYS
AI-powered delivery of verified requirements, clickable UI/UX, and a working MVP for healthcare and SaMD products—without sacrificing traceability or validation later on.
From first interview to MVP and documentation
vs. typical 30–40 day discovery cycles
Spec‑driven, AI‑assisted dev cuts build costs
What You Get
In short: Requirements + Clickable Mockups + MVP — everything needed to move into validation and full SaMD development.
Product Definition + Vision & Scope
MVP-ready product definition, context, and regulatory framing
Everything needed to describe the SaMD product: who it is for, how it fits into the clinical and technical environment, and how it will be classified and justified under MDR and related standards.
- Intended Purpose / Use & Device Description
- High-Level System Context & Architecture
- Project Vision & Scope
Requirements & Traceability
Verified requirements and initial traceability baseline
A coherent initial requirements package that captures user needs, functional and non-functional requirements, and their traceability.
- Functional and Non-Functional Requirements
- User Needs documented and linked
- Traceability (Needs → Requirements)
MVP + V&V Pathway
Working MVP plus a clear path into validation and development
A functional MVP built directly from the verified specs, plus a plan for verification, validation, and further SaMD development phases.
- MVP implementing the minimal viable scope of requirements
- Real integrations and data flows for key SaMD scenarios
- Spec-driven, AI-assisted implementation
- 3–7 short sprints to stabilise and tune
- Defined Verification & Validation pathway with our partner network
10-Day MVP Process
Day 0: Stakeholder Interview
Certified analyst conducts comprehensive interviews with key stakeholders to gather project requirements, goals, and context. AI processes transcripts to extract key information.
Days 1-2: Vision & Scope + Requirements
AI-powered generation of Vision & Scope and complete Requirements documentation. Certified analyst reviews, refines, and ensures alignment with stakeholder needs and regulatory context.
Days 3-4: User Stories & Flows
AI transforms requirements into structured user stories, flows, and acceptance criteria. Stories organized, prioritized, and validated by certified analyst for spec-driven development.
Days 5-10: MVP Build & First Iteration
Using the verified requirements and stories, we build a working MVP on real data and integrations. By day 10 you have a functional product ready for short daily sprints and, later, SaMD validation.
How We Work with You
10-Day MVP Package
Fixed-scope engagement where we take you from stakeholder interview to verified requirements, clickable UI/UX, and a working MVP for your healthcare or SaMD product.
- ✓Certified analysts use our own platform and methodology to drive the process
- ✓In about 10 days: requirements package, clickable mockups, and functional MVP
- ✓Spec-driven, AI-assisted development with ~40% cost reduction and SaMD-ready traceability
Validation & Development
Once the MVP is ready, we continue with short sprints, verification/validation support, and—when needed—on-prem or VPC deployments for your SaMD lifecycle.
- ✓Daily or short sprints to refine and stabilise the MVP
- ✓Network of partners for testing, verification, and validation in regulated environments
- ✓Option to deploy the platform into your VPC as part of a longer-term SaMD roadmap
Case Studies
Real healthcare and life-sciences systems delivered with our methodology, platform, and spec-driven development.
Ready to Plan Your MVP?
You get requirements, clickable mockups, and an MVP built from the same specs. Then we support validation and further development for SaMD products.