10-Day SaMD MVP Package
From first stakeholder interview to SaMD-ready requirements, clickable UI/UX, and a working MVP in about 10 days—led by certified analysts using our own AI-powered methodology.
Service Overview
The VNcent 10-Day SaMD MVP Package is a methodology-first engagement that takes you from stakeholder interviews to a working MVP for your healthcare or SaMD product. Certified analysts drive the process using our own platform, combining rigorous requirements work with spec-driven, AI-assisted implementation.
Days 1–5 focus on product definition, SaMD-ready requirements, and clickable UI/UX mockups built directly from those specs. Days 6–10 are dedicated to implementing the minimal viable scope of requirements as a working MVP, wired to realistic data flows where it matters.
This service is ideal for healthcare teams and SaMD innovators who need both documentation and a functional MVP, without maintaining their own BA or architecture team. You bring the clinical problem and constraints; we bring the methodology, tooling, and delivery team.
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 SaMD MVP Process
Days 1–2: Stakeholder Interviews & SaMD Context
Certified analysts run focused sessions with clinical, business, and technical stakeholders. AI processes transcripts to extract intended purpose, user needs, constraints, and regulatory context.
Days 3–4: Product Definition, Vision & Scope
We crystallise the SaMD product: intended purpose/use, device description, high-level architecture, and initial regulatory strategy. Everything is captured in a single, coherent definition package.
Day 5: Requirements & Traceability Baseline
AI-assisted drafting of functional and non-functional requirements, user needs, and the first traceability links between them—reviewed and corrected by analysts with SaMD experience.
Day 6: Clickable UI/UX From Specs
Clickable UI/UX mockups are generated strictly from the written specs. Stakeholders can see end-to-end flows, but this is still design, not the MVP itself.
Days 7–10: MVP Build & V&V Pathway
Engineers implement the minimal viable scope as a working MVP, wired to realistic data flows where it matters. In parallel, we outline the verification & validation pathway and next sprints.
Our Focus on Quality
100% Verified Requirements
Every requirement is verified for completeness, consistency, and alignment. Complete traceability from vision to implementation.
Certified Business Analysts
Every project is assigned a certified business analyst who validates, refines, and ensures enterprise-grade quality standards.
Enterprise-Grade Standards
Documentation follows industry best practices and standards. Structured, consistent, and ready for development teams.
AI + Human Validation
AI accelerates generation, certified analysts ensure accuracy. Best of both worlds: speed and quality.
Our Focus on Compliance
VNcent is ISO certified and specializes in compliance-ready documentation for regulated industries. Our processes are designed to meet the strictest regulatory requirements.
ISO 27001
Information Security Management
ISO 9001
Quality Management Systems
ISO 13485
Medical Devices Quality Management
Specialized Support: We provide compliance-ready documentation for GDPR, HIPAA, PCI-DSS, FDA regulations, and customer-specific frameworks. Our certified analysts understand regulatory requirements and ensure your documentation meets audit standards.
Flexible Pricing Based on Compliance Needs
Our pricing is flexible and scales based on your compliance requirements. More boundaries and constraints = higher complexity = higher price. This ensures you only pay for what you need.
Starting at $3,000
Base package includes Vision & Scope, Requirements, User Stories, and Clickable Mockups for standard projects with no compliance requirements.
- No compliance requirements (1.0x)
- Standard review cycles (1–2 cycles)
- Full package deliverables
Compliance Multipliers
- GDPR:1.1x
- Industry Standards (HIPAA, PCI-DSS):1.4x
- Medical Device (ISO 13485, FDA):1.6x
- Customer-Specific Frameworks:1.8x
Talk to us to get an estimate tailored to your regulatory context and product complexity.
Request a QuoteReferences
"I was genuinely impressed by the speed and quality of the analytical document. The depth, clarity, and structure exceeded expectations, it not only captured the interview content accurately but also enriched it with valuable details. The document required almost no edits and is a solid foundation for further work"
— Patrik S., PhD
Frankfurt, Germany
Principal Digital Health Consultant
Ready to Get Started?
Transform your discovery process. Get complete documentation and a first working MVP in about 10 days with certified analysts and AI-powered tools.