Our Process
How we build software that is compliant from day one.
Discovery 1–2 weeks
A focused phase to understand your challenge, map the regulatory landscape, and design the right system — before we build anything.
- Stakeholder mapping and use case definition
- Identify applicable regulations (MDR, IVDR, IEC 62304, ISO 14971, IEC 62366, and more)
- Preliminary software safety classification (Class A / B / C)
- System architecture sketch and scope definition
- Deliverable: Discovery summary with system design, regulatory roadmap, and clear next steps
Analysis 2–4 weeks
Regulatory classification, gap analysis, and scope definition
- Formal software safety classification
- Gap analysis against existing documentation / QMS
- Define development scope, milestones, and acceptance criteria
- Risk management plan (ISO 14971)
- Deliverables: Project plan, gap analysis report, risk management plan
Development 2–12 months
Engineering with integrated documentation — in your QMS or ours
- Iterative development with continuous verification
- Software requirements specification (SRS)
- Software architecture & detailed design
- Risk analysis updates with each iteration
- Usability engineering file (IEC 62366) where applicable
- Deliverables: Working software, SRS, architecture doc, risk file, design history
Verification 2–6 weeks
Testing, traceability, and review against the requirements specification
- Unit, integration, and system testing
- Full requirements traceability matrix
- Formal review of all documentation artifacts
- Deliverables: Test reports, traceability matrix, verification summary
Handover 2–4 weeks
Submission-ready documentation package for the notified body
- Compile technical documentation package
- Support during notified body audit / review
- Knowledge transfer and training
- Deliverables: Technical file, release notes, training materials
After Go-Live
Post-market surveillance, application support, and ongoing maintenance
Timelines depend on regulatory classification, system complexity, and your existing documentation. We'll give you a realistic estimate after Discovery.
MVP Fast-Track
Whether you're a startup validating a medical device concept or an enterprise building a proof-of-concept — validate your idea with a working MVP, documented per IEC 62304 from day one. Nothing is wasted when you scale up.
4–8 weeks from kickoff to validated MVP
1 — Define & Build
- Gather and document requirements (user needs, intended use)
- Classify risk & define regulatory scope
- Build a working, validatable MVP
- Document per IEC 62304 as we go — not after the fact
2 — Validate & Decide
- Client validates the MVP against their use case
- Core verification against requirements
- Decision point: scale up, pivot, or iterate
What you get
- Working MVP your stakeholders can touch
- IEC 62304 documentation baseline (SRS, architecture, risk) — ready to build on
- Clear scale-up roadmap for full conformity
Book a free introductory call — we'll discuss your project and outline actionable next steps.
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